Taking Inventory: A Framework for Understanding …...HeAltH And HuMAn ServiCeS AgenCy dePArtMent of...

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CALIFORNIA HEALTHCARE FOUNDATION MAY 2014 Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

Transcript of Taking Inventory: A Framework for Understanding …...HeAltH And HuMAn ServiCeS AgenCy dePArtMent of...

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CALIFORNIA HEALTHCARE FOUNDATION

May 2014

Taking Inventory: a Framework for Understanding Health Care Regulation and Oversight in Ca

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Contents

3 Introduction

3 Project Scope and Methodology

4 Overall Distribution of Regulatory Oversight Responsibilities

9 Initial Applications, Renewals, and Fees

11 Funding for Regulatory Oversight Functions

13 Frequency and Intensity of Oversight

15 Facility Compliance Domains and Currency of Requirements

17 Complaints and Enforcement

18 Collection and Public Availability of Information

19 Communication Between Government Agencies

21 AppendicesA: State-Regulated Categories of Health Care Facilities

and Professionals

B: Profiles of State Health Care Regulatory Bodies

C: Project Methodology

About the AuthorBrenda G. Klütz is managing principal of B&r Klütz Consulting, LLC, an indepen-dent consulting firm based in Sacramento, California. The firm specializes in public health policy and regulatory compliance. Ms. Klütz has more than 30 years of California state administrative, legislative, and health policy experience. Ms. Klütz previously served as deputy director of the Licensing and Certification Program for the California Department of Health Services.

About the FoundationThe California HealthCare Foundation works as a catalyst to fulfill the promise of better health care for all Californians. We support ideas and innovations that improve quality, increase efficiency, and lower the costs of care. For more information, visit www.chcf.org.

© California HealthCare Foundation, 2014

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$$ Data Collected and Information Maintained

$$ Public Availability of Information About the Regulated Entity

$$ Communication and Data Sharing Between Government Agencies

Project Scope and Methodology

The purpose of this project is twofold: (1) to document and improve awareness of the state government’s framework for regulating health

care-related facilities, professionals and paraprofession-als, and medical devices and equipment; and (2) to begin identifying opportunities and barriers to improving the efficiency and effectiveness of state regulatory oversight, and thereby ultimately to increase consumer protection. As used in this report, “facilities” includes inpatient and outpatient health care settings, services such as hospice and home health care, and health care-related sites such as drug and medical device manufacturers and pharmacy wholesalers. “Facilities” also includes facility designa-tions — for example, the designation of a hospital as a trauma center or the issuance to a hospital of a certificate of registration for laboratory or radiology.

The scope of the project includes:

$$ An inventory of the categories of the regulated community: facilities, professionals, and devices, and general characteristics of the oversight func-tions related to these categories

$$ An inventory of databases and other information maintained about the regulated entities, the uses of that information, and its public availability

$$ An inventory of formal and informal communica-tions and working relationships between state government entities with regulatory responsi-bilities, including interagency agreements and delegation orders

$$ Examples of how some health care providers are regulated by multiple federal, state, and local government entities

It should be noted that the scope of this project did not include important state government regulatory

Introduction

California state government has long been pri-marily responsible for regulation and oversight of health care facilities and professionals, and

of providers of medical devices. These responsibilities are widely distributed among multiple state agencies, departments, boards, bureaus, and commissions. In particular, the California Health and Human Services Agency (CHHS) and the Department of Consumer Affairs (DCA) of the Business, Consumer Services, and Housing Agency are responsible for regulating 73 categories of facilities and facility designations, 87 categories of health care professionals, and one category of medical devices. CHHS’s responsibilities are spread over six departments while DCA has 18 largely autonomous boards, commit-tees, and programs that regulate and oversee health care facilities and professionals. (A list of the entities regu-lated is provided in Appendix A. A list and profile of the CHHS and DCA departments and agencies responsible for regulation and oversight, including those that did not respond to this project’s survey request, is provided in Appendix B.)

Given this wide distribution of regulatory authority, it can be difficult to know exactly what is regulated by whom, and how to get basic information or file a complaint about a regulated entity. The focus of this project is to improve understanding of what is regulated, how these various state government agencies work separately or together to oversee the delivery of health care services, and what information about such oversight is available to the public.

The project inventoried the state government’s regulatory oversight responsibilities through surveys completed by state departments, boards, committees, and programs. The survey responses provide information about the general characteristics of each program, including the following categories:

$$ Regulatory Oversight Responsibilities

$$ Initial Applications, Renewals, and Fees

$$ Funding for Regulatory Oversight Functions

$$ Frequency and Intensity of Oversight

$$ Facility Compliance Domains and Currency of Requirements

$$ Complaints and Enforcement

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Overall Distribution of regulatory Oversight responsibilities

Findings$$ Oversight of California’s health care facilities, profes-sionals, and medical devices is widely distributed among two state agencies, seven state departments, and 18 largely autonomous boards and commissions. For some regulated entities, different state depart-ments and agencies share responsibility for basic licensure and certification.

$$ The wide distribution of responsibilities may pres-ent a barrier to an effective and efficient regulatory oversight system unless there is useful, organized communication between state entities.

Opportunities$$ Consider the advantages of consolidating state oversight functions for selected facility/provider categories.

$$ Examine the various systems of care and how the state government’s oversight of the components of those systems represents an efficient use of public funds, and is well-coordinated and seamless from the standpoints of both consumers and providers of services.

$$ Consider the advantages of consolidating health care-related professional licensure/certification under one cabinet official, so that responsibility for facilities and professionals is under the same state agency.

As shown graphically below, there are more than 160 categories of health care facilities or facility designa-tions, professionals, and medical devices regulated by California state government bodies, and this regulation is widely distributed among individual agencies, depart-ments, and programs under both CHHS and DCA. (See Tables 1 and 2 on page 5.)

responsibilities related to financing of, or payment for, health care services. Nor did it include responsibilities specifically related to public or environmental health.

The project’s inventory and analysis were informed by survey responses received from state government regu-latory bodies and by review and comments on the draft of this report by those government entities. Of 73 health care–related licensed facility categories, 68 completed surveys (93%) were received; these included surveys from the agencies for all 61 categories regulated by CHHS. Of 87 categories of professionals, however, only 42 surveys (48%) were submitted. A survey was also submitted for the single category of medical devices/equipment. The analysis in this report is based on the responses. This project was also informed by interviews with key state health care thought leaders. (A more detailed discussion of the methodology used in the project, including the survey tools, can be found in Appendix C.)

While the survey responses from departments that regu-late facilities included nearly all facility categories, the lack of response (52%) from some state entities that regulate professionals was significant. In particular, 13 of the 18 boards, bureaus, and committees under the DCA failed to provide survey responses. Consequently, while the report’s information about regulation of facilities and designations is clearly representative, information about regulation of professionals is considerably less so. Nevertheless, the information gathered about profes-sionals provides useful indications of the state of their regulation, so this report includes information about them in accordance with those survey responses that were received.

This report provides an overview of the information collected from the survey responses plus findings and opportunities for improving the effectiveness and effi-ciency of state government oversight of health care facilities, professionals, and devices, based on that infor-mation.

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Single Category of Provider, Multiple AgenciesOver the years, state government has reorganized the way in which health care is regulated. Some “super departments” have been created to oversee many entity categories within a single system or environment. But smaller departments or subagencies continue to exist that specialize in the provision of services to a specific population, or a specific category of services. Also, regulated facilities or providers themselves may take on multiple components or programs, requiring them to seek separate regulatory approval, sometimes having to

Responses to the surveys in this project highlight two circumstances in which the wide distribution of regula-tory responsibilities might affect the effectiveness and efficiency of oversight programs:

$$ Where a single category of provider must deal with multiple state agencies to obtain basic approvals for licensure and certification

$$ Instances in which a system of care, and the individual facilities and professionals who work within that system, operate under the authority of multiple state agencies.

Table 1. Categories and Total Number of Health Care Facilities, Professionals, and Medical Devices Regulated by California State Agencies

HeAltH And HuMAn ServiCeS AgenCy dePArtMent of ConSuMer AffAirS

CategoriesNumber of Regulated Entities/

Individuals Reported CategoriesNumber of Regulated Entities/

Individuals Reported

Facilities 61 73,354 12 10,973

Professionals 29 454,771* 58 373,349*

Devices 1 80 0 0

*The actual number of professionals is considerably greater than the numbers represented by the survey responses since responses were received from only 48% of state government agencies regulating professionals.

Table 2. Distribution of Health Care Regulatory Oversight Among California State Agencies

fACilitieS* ProfeSSionAlS deviCeS

Health and Human Services Agency 61 29 1

Department of Aging 1 0 0

Department of Public Health 40 22 1

Department of Health Care Services† 9 2 0

Department of Social Services‡ 7 1 0

Emergency Medical Services Authority 2 3 0

Office of Statewide Health Planning and Development 2 1 0

Department of Consumer Affairs (18 boards, committees, and programs)

12 58 0

*The Department of Forestry and Fire Protection, Office of the State Fire Marshal, is responsible for fire/life safety standards for health facilities, but was not included in the scope of this project.

†The Department of Alcohol and Drug Programs (DADP) provided survey responses. However, as of July 1, 2013, the oversight functions and authority of the DADP were transferred to the Department of Health Care Services (DHCS), so the DADP survey response totals are included under the DHCS figures.

‡The Department of Social Services responses included figures for mental health rehabilitation and psychiatric health facilities. However, as of July 1, 2013, oversight of these entities was transferred to DHCS, so the survey response figures for those entities are included in the DHCS figures.

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into suspense (limiting the types of care that may be provided) in order to license it as an MHRC.

Since CDPH is also responsible for other behavioral health care-related oversight (including licensing acute psychiatric hospitals, chemical dependency recovery hospitals, and psychology clinics), it might be more efficient to centralize oversight responsibilities for all categories of behavioral health facilities under the single CDPH umbrella.

$$ Programs for all-Inclusive Care for the Elderly (PaCE). DHCS is the state entity with primary responsibility for regulating PACE. However, PACE organizations are required to hold separate licenses as primary care clinics, adult day health care centers, and home health agencies, all of which are licensed by CDPH.

California law permits PACE organizations to seek exemption from licensure for these three categories if they submit policies and procedures that demonstrate their ability to comply with licensing requirements. If the exemption is granted, they are no longer under the oversight authority of CDPH but are under the exclusive oversight of DHCS. Since this exemption process already permits some PACE organizations to move exclusively under DHCS, there exists an oppor-tunity to streamline oversight of all PACE organizations by doing away with the separate, multiple licensing altogether and vesting exclusive authority over them with DHCS.

distribution of responsibility Within Systems of Care A separate, related issue is the extent to which the dis-tribution of regulatory oversight responsibilities among different agencies helps or hinders broad systems of care for specific populations (based on commonalities of age, diagnosis, or need for services). Examples of such sys-tems of care include programs and services for children, for persons with need for long term care services and support, and for persons with intellectual disabilities. Regulatory structures for facilities and professionals that work within such a particular system of care generally are not designed to be responsive to such systems.

The provision of care for behavioral health/mental health/substance use disorders is an example of the potential for disconnects between the regulation of the facilities

meet different standards with each. At the same time, the different state agencies overseeing the same health care entities may remain isolated from each other, despite their common purposes and site of responsibility. Such overlapping regulatory responsibility can create unnec-essary complexity for the regulated entity and confusion or difficulty on the part of the public in obtaining health care from the entity.

The survey responses in this project suggest that there are at least three examples of single categories of pro-vider where basic licensing and certification functions are shared by more than one agency. (This does not include situations in which other types of federal, state, or local approvals are necessary to do business. For a discussion of those issues, see “Role of Federal and Local Governments,” below.) These instances of overlap-ping authority may present opportunities to consolidate regulatory oversight responsibility, thereby increasing efficiency for the state, decreasing complexity for the entity, and enhancing clarity for the public. An example of such consolidation is the initiative that relocated the Department of Managed Health Care under CHHS.

$$ adult Day Health Care. Adult day health care centers are licensed by the California Department of Public Health (CDPH), Licensing and Certification. But they may also be certified as Community-Based Adult Services programs by the California Department of Aging (CDA), under arrangement with the Department of Health Care Services (DHCS). Thus, three agencies (CDPH, CDA, and DHCS) may have some licensing jurisdiction over a single dual-certified center.

$$ Psychiatric Health Facilities/Mental Health rehabilitation Centers. As of the 2013–14 state budget, DHCS is now responsible for licensing and certifying psychiatric health facilities (PHF) and mental health rehabilitation centers (MHRC). Also, the Centers for Medicare & Medicaid Services (CMS) contracts with a private entity to conduct routine fed-eral surveys of PHFs, to determine compliance with the Medicare Conditions of Participation. However, CMS may also request the California CDPH to con-duct complaint investigations or validation surveys on its behalf. Also, an MHRC may be licensed either as a separate freestanding facility or as a part of a skilled nursing facility (SNF), which is licensed and certified by CDPH. Or, the facility’s SNF license may be put

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and professionals that provide the services, and the sys-tem of care for populations who need those services. The oversight of facilities that treat mental health, behav-ioral health, and substance use disorders is spread over multiple state departments (see “Regulatory Oversight for Categories Related to Behavioral Health–Related

Systems of Care” below). This extensive multiplicity of regulatory authorities raises an important question: To what extent do these state agencies communicate with each other about common policies regarding scope of services, ease of access, quality of care, and continuity of care?

regulatory Oversight for Categories related to Behavioral Health–related Systems of CareThe following is a list of the distribution for regulatory oversight of facility and professional categories related to behavioral health–related systems of care. These responsibilities are under the jurisdiction of two state agencies and four state departments.

CdPH licenses and/or certifies the following categories:$$ Acute Psychiatric Hospitals

$$ Chemical Dependency Recovery Hospitals

$$ General Acute Care Hospitals with Psychiatric Units and/or Outpatient Psychiatric Services

$$ Primary Care Clinics and other clinics (Rural Health Clinics and FQHCs) that provide integration of primary care and behavioral health treatment

$$ Psychiatric Health Facilities (limited oversight upon request by CMS)

$$ Psychology Clinics

$$ SNFs that operate a Special Treatment Program, a designation now under the authority of DHCS

dHCS licenses and/or certifies the following categories:$$ Alcohol or Drug Counselors in licensed and certified facilities

$$ Alcoholism or Drug Abuse Recovery or Treatment Facility

$$ Driving-Under-the-Influence Program

$$ Mental Health Rehabilitation Centers

$$ Narcotic Treatment Program

$$ Psychiatric Health Facilities

$$ Residential Alcoholism Drug Abuse Recovery or Treatment Facility

dSS licenses the following categories:$$ Adult Residential Facilities

$$ Group Homes

$$ Social Rehabilitation Facilities

dCA boards and bureaus license related professions:$$ Board of Behavioral Science

$$ Board of Registered Nursing

$$ Board of Vocational Nursing and Psychiatric Technicians

$$ California Board of Psychology

$$ Medical Board of California

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role of Federal and local governmentsWhile California state government regulates a significant portion of the health care delivery system, the federal and local governments also have a key oversight role.

Federal GovernmentOther than participation in Medicare and Medi-Cal, the federal government plays no major role in regulating the licensure of health care professionals or facilities, defer-ring to the state to perform this function. Where federal and state governments do share oversight responsibility, state government requirements may exceed or be more specific than federal requirements.

The following are some of the most significant areas in which the federal government has a significant role in regulating health care facilities and professional prac-tices:

$$ Regulation of drugs and medical devices and equipment — the Federal Drug Administration (FDA) has authority over drugs; medical devices; radiation-emitting products; vaccines, blood, and biologics; and other similar products and devices

$$ Regulation by CMS of Conditions of Participation (COP) in Medicare and Medicaid for all categories of eligible facilities and professionals, and stan-dards for payment to enrolled providers; under the California State Plan, the federal COP for health care facilities also applies to providers seek-ing Medi-Cal enrollment

$$ Enforcement of federal requirements — the FDA and CMS enforce their own regulations, and the federal Department of Justice participates in cases of prosecution

$$ Enforcement of controlled substances laws and regulations by the federal Drug Enforcement Agency

$$ Enforcement actions against individuals through reporting to the National Practitioner Data Bank, which centrally stores records of disciplinary actions, including state enforcement actions

$$ Coordination of efforts to foster competition in the health care marketplace through the Federal Trade Commission and the Anti-Trust Division of the federal Department of Justice

$$ Patenting of drugs or devices through the Patent and Trademark Office

Local GovernmentsLocal governments have jurisdiction over facilities and providers in several areas, including:

$$ Local authorities approve new construction or renovations, in accordance with state and local laws.

$$ Facilities and providers may be required to obtain a local business license.

$$ Local governments oversee the density of certain types of health care facilities in residential areas.

$$ Local emergency medical services authorities, in conjunction with other county entities, have authority to approve hospital trauma designations and emergency services plans.

$$ Local fire authorities inspect facilities for compli-ance with local fire safety requirements and issue fire clearances and maximum occupancy permits.

$$ Local public health departments have authority to inspect the dietary preparations, services, and spaces in many categories of facilities.

$$ Facilities are required to report infectious disease outbreaks to local public health departments.

$$ Mandated reporters are required to report alleged instances of abuse or neglect to local law enforce-ment, adult protective services, child protective services, or local ombudsman programs.

$$ All facilities and offices must meet local zon-ing requirements and building standards for their building category and the types of services provided; however, some categories of health care facilities are under the building authority of the state Office of Statewide Health Planning and Development rather than local building authority.

With regard to medical devices, equipment, and drugs, local governments have minimal direct regulatory over-sight authority. However, if a medical device, equipment, or drug presents a public health problem or challenge, a local public health department may become involved to protect the welfare of Californians within its jurisdiction.

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Facilities Of the 68 (out of 73) categories of health care facility or other health care site:

$$ 57 review prior compliance history

$$ 48 include an onsite inspection

Professional Licensure or Certification Of the 42 (out of 87) categories of health care profes-sional:

$$ 16 have age requirements

$$ 37 require payment of a fee

$$ 28 require criminal record clearance

$$ 6 have reciprocity with other states (which may have workforce implications)

$$ 21 require a minimum number of hours of education and training

For a more complete overview of application processes and requirements for licensure, certification, registra-tion, or other designation, based on this project’s survey responses, see Table 3 on page 10.

In addition to inconsistencies in required application information and eligibility standards, there is consider-able variance in the use of online technologies for license or certification application and renewal. (See Table 4 on page 10.)

Ready online access to applications and other forms, as well as online information about the process of initial application for or renewal of state licenses, certifica-tions, registrations, or other designations, can be very helpful to both prospective applicants and the licens-ing body. But as Table 4 shows, while initial applications are often available to download, applicants may not be able to fill in the application, return the applications, or pay fees online. Also, most state entities use regular mail notification of upcoming renewals. These largely paper processes require more time and costs than necessary for both the applicant and the state entity, particularly given relatively simple existing online technology that can enable these tasks to be performed.

Initial applications, renewals, and Fees

Findings $$ There is considerable variability in the requirements for initial licensure, certification, and other designa-tions within categories of facilities and professionals.

$$ The application and renewal processes do not make full use of available technology that could save both time and costs for the applicant and the state.

Opportunities$$ Examine the processes and requirements for issu-ance and renewal of licensure for similar categories of professionals and facilities, to ensure that minimum professional requirements/qualifications established in state law are met.

$$ Improve the use of technology to provide online access to, and processing of, applications and payment of fees for prospective providers.

State regulatory programs require prospective applicants to meet specific eligibility standards and to submit suffi-cient documentation and other information. The process is intended to determine the applicant’s suitability and eligibility for licensure, certification, or other designation, based on standards for the particular category, and to place appropriate restrictions on them in their operation of a facility or in their performance as a health care pro-fessional. The underlying purpose of the requirements is to protect public health and safety.

The process and requirements vary widely by category of facility, profession, or medical device. While in some cases there may be good reasons for the variances, in-depth review may show that certain differences cannot be justified and should be remedied. The following are among the more noteworthy differences among qualifi-cations, as revealed through the surveys.

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Table 3. Major requirements for Licensure or Certification

FACilitieS (68 of 73 categories)

PrOFeSSiOnAlS (42 of 87 categories)

deviCeS (1 category)

Application 66 41 1

Fee 56 37 1

Desk Review 37 40 1

Proof of Education/Training Not applicable 41 Not applicable

Testing Not applicable 32 Not applicable

Onsite Review/Inspection 48 3 0

Documentation from Other Agency 34 31 0

Age Not applicable 16 Not applicable

Reciprocity Not applicable 6 Not applicable

Criminal Background Check 23 28 Not applicable

Prior Compliance History 57 Not asked Not asked

Minimum Amount of Education/Training Not asked 21 Not applicable

Other* 15 19 0

*Includes requirements such as business ownership information, federal certifications, financial affidavits, lease/property ownership documentation, and evidence of policies and procedures.

Table 4. Tasks That applicants Can Perform Online

FACilitieS (68 of 73 categories)

PrOFeSSiOnAlS (42 of 87 categories)

deviCeS (1 category)

Obtain Initial Application 60 37 0

Submit Initial Application 2 9 0

Pay Initial Fees 8 8 0

Obtain Renewal Applications 20 30 0

Submit Renewal Applications 1 8 0

Pay Renewal Fees Online 7 6 0

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opportunity to reexamine the workload associated with these responsibilities and adjust funding accordingly.

Another source of funding for state regulatory oversight might be Medicaid (Medi-Cal) taxes. For specific cate-gories of providers there has been an increased use of Medicaid provider taxes, or other taxes or fees, to meet state matching funds requirements and thus maximize the federal matching funds available for provider reimburse-ment. Although the revenue generated from provider taxes cannot be used for the administration of Medi-Cal, it can be used for “other health care items or services . . . on which the State has enacted a licensing or certification fee” subject to specific requirements [42 CFR 433.56(a)(19)]. This seldom-used provision presents an opportu-nity to identify those regulatory responsibilities related to licensing and certification for which the use of a provider tax would be permitted.

This project’s survey respondents were asked about the funding sources for each regulatory oversight function. Table 5 (on page 12) shows their responses.

Funding for regulatory Oversight Functions

Finding$$ The operational costs of the vast majority of regula-tory oversight functions are funded almost entirely by state fees from the regulated community; other categories are funded entirely by federal funds or a combination of federal funds and state fees; only a few categories have funding through the State General Fund.

Opportunities$$ For those regulatory oversight functions funded by the General Fund, there may be opportunities to shift to non-General Fund sources:

$$ Use of allowable Medi-Cal provider taxes could produce a match to federal funds to pay the costs of licensure and/or certification.

$$ Use of licensing fees paid by the regulated community could replace funding by the State General Fund.

Over the past several years, state budget constraints have led to efforts to minimize use of the State General Fund to support regulatory oversight. The most com-mon alternative to the General Fund has been user fees, which pass the cost of state regulatory oversight func-tions to the regulated community. As a consequence of this increased reliance on fees, the amounts of those fees has tended to increase. When fees were first established for specific categories of facilities or providers, some were set at an amount based on fees paid in other states, or fees paid by analogous categories, but these amounts are now insufficient to make up for the loss of support from the General Fund. Some regulatory oversight agen-cies must seek legislation to change fees, while others have the authority to change fees through regulation or through the annual budget process.

Also, over time many oversight responsibilities have increased in complexity and/or demand on state resources, in many instances leading to a workload-based setting of fees. Where regulatory oversight programs continue to use the General Fund to pay the cost of regulating facilities or professionals, there may be an

Mixed State and Federal Funding Must Be ConsideredIt should be noted that some state entities conduct regulatory oversight under federal authority or under both state and federal authority. The funding sources for these responsibilities can vary greatly, with the federal government paying a share of costs for work completed under its authority. For instance, there is a certain percentage of workload associated with hospital licensure and certification under Medicare and Medicaid. Consequently, the sources of funding for hospital oversight depend on the type of oversight activity being performed (whether under state licensing or federal Medicare and/or Medicaid authority). This leads to a some-what complicated mix of funding sources that must be considered when proposing any changes to state funding sources.

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$$ DHCS administrative costs associated with approving/certifying PACE organizations might meet the criteria for Medicaid provider taxes. If the responsibilities for the required licenses (clinic, ADHC, and home health agency) for PACE orga-nizations were consolidated under DHCS, the Medicaid taxes paid by PACE organizations could not exceed the licensing fees they are currently paying to CDPH. This would result in the regula-tory oversight program for PACE organizations being funded by a combination of federal funds and Medicaid provider taxes instead of requiring General Fund monies as a match.

Alternatively, if the fees currently paid by PACE organizations to CDPH for their three-part licen-sure were instead paid to DHCS (and the oversight functions consolidated), that might make over-sight of PACE organizations self-funding, thereby eliminating one barrier to continued growth of the

The following are examples of possible alternative fund-ing sources for selected programs:

$$ If the licensure and certification of Adult Day Health Care (ADHC) and Community-Based Adult Services (CBAS) centers were consolidated under CDA, the administrative costs of certifying CBAS providers might be paid for by a combination of licensing fees and Medicaid provider taxes (with a federal match).

Alternatively, if a portion of the licensing fees currently paid by ADHCs to CDPH were allocated to CDA to support consolidation of ADHC/CBAS licensing and certification at CDA, the revenue collected might pay for both the ADHC licensing and the state match portion of the CBAS certifica-tion oversight functions.

Table 5. Funding Sources for State regulatory Oversight

FACilitieS (68 of 73 categories)

PrOFeSSiOnAlS (42 of 87 categories)

deviCeS (1 category)

regulation under State authority

100% Fee Supported 43 33 1

Mix of Fees and Federal Funds 2 1 0

Mix of State Funds, Federal Funds, and User Fees 4 0 0

Mix of State and Federal Funds 2 0 0

100% Federal Funds 2 0 0

Other 4 3 0

Not Applicable or Did Not Answer 11 5 0

regulation under Federal authority

100% Fee Supported 12 0 0

Mix of Fees and Federal Funds 15 0 0

Mix of State and Federal Funds 1 0 0

Mix of State Funds, Federal Funds, and User Fees 0 0 0

Mix of State Funds and Fees 0 0 0

100% Federal Funds 1 0 0

Other (including mix of state plus fees, and state-only) 3 4 0

Not Applicable or Did Not Answer 36 38 1

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PACE program. The fees could be prorated based on the number of participants for each organiza-tion.

$$ Some categories of community care facilities are still supported by a portion of the State General Fund. Additional analysis is required, but calcula-tion of the increased fees necessary to eliminate the General Fund portion could be coupled with a workload analysis of the costs of increased periodic onsite surveys to require the regulated community to pay for the costs of oversight.

Frequency and Intensity of Oversight

Findings$$ Oversight of facilities most often includes an onsite review, while oversight of professionals includes responding to complaints and verification of compli-ance with continuing education credits.

$$ The required frequency of facility onsite reviews var-ies considerably, from annually to once every seven years; some state entities may not be complying with required oversight intervals.

$$ The scope and content of facility onsite reviews, and the qualifications and training of state staff that con-duct those reviews, can vary significantly.

$$ Some routine oversight functions are contracted or delegated to entities outside the state agency responsible for oversight; delegation is most often made from the state to one or more counties.

Opportunities$$ Review the categories of professionals and facilities that do not have routine oversight conducted to determine if this practice is appropriate, and review the required frequency of oversight where it exists, to determine its sufficiency.

$$ Consider providing the authority for state entities to conduct random onsite reviews of professionals who practice from their own offices.

$$ Review the extent to which state entities comply with required oversight frequency.

$$ Review state staff qualifications and training to con-duct oversight activities, and the scope of oversight conducted given the types of services provided.

$$ Review the effectiveness and efficiency of contracting out or delegating oversight functions.

Periodic oversight is a common way to determine the extent to which regulated entities comply with the stan-dards for holding a license, certificate, registration, or other state designation. The type of regulated entity, the intensity of services provided by the entity, and the man-dates under which state government regulates the entity, all determine the nature and frequency of that required oversight.

Oversight for some programs consists of monitoring the requirements for license renewal (e.g., continuing education requirements and payment of a fee), and/or responding to specific complaints. Onsite inspections are another form of monitoring, and are most often used by state regulators for oversight of facilities.

In some instances, the oversight function is contracted out or delegated. Contracting out or delegation can be for the entire oversight function, but most often it consists of contracting with one or more counties for specific over-sight functions. Examples include delegating to counties the designation of trauma centers and emergency medi-cal services plans, contracting with Los Angeles County the responsibility for state licensing and federal certifi-cation of health care facilities, and contracting with Los Angeles and San Diego County Radiation Management for oversight of certain categories of professionals who handle equipment with radioactive materials.

Based on this project’s survey responses, routine over-sight was provided as shown in Tables 7 through 9 on page 14.

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14California HealthCare Foundation

Table 7. Periodic Oversight Required and Contracted Out

RequiRed* ContRaCted out†

Facilities (68 of 73 categories)

66 34

Professionals (42 of 87 categories)

28 13

Devices (1 category)

1 Not asked

*The focus of this survey question was whether periodic oversight is required, not if the state agency meets the requirements.

†Can mean in its entirety, for selected function only, or only with one or more counties.

Table 8. Nature of Periodic Oversight

FaCilities (68 of 73 categories)

PRoFessionals (42 of 87 categories)

deviCes (1 category)

Any 66 28 1

Contracted Out*

34 13 Not asked

Onsite 52 8 1

Other† 14 20 0

Blank 2 14 0

*Contracting out can include partial contracting out or contracting with a specific county.

†Some indicated “Other” to mean the Legislative Sunset Review process, rather than regulatory oversight of facilities or professionals.

Table 9. Required Periodic Oversight Cycle for Facilities (68 of 73 categories)

state* FedeRal

Annual 4 3

Biennial 14 2

Triennial 11 2

Other† 30 14

Not Applicable 8 31

Did Not Answer 1 16

*A single category of facility can have periodic oversight cycles under both state law and federal law. Those cycles may be different.

†Other oversight cycles mentioned in responses include: community care facilities (six categories), which are surveyed no less than once every five years (with a 30% random sample of facilities receiving a more frequent survey); some delegated (by law) oversight depends on the cycle estab-lished by the local jurisdiction; some vary according to a system of priority (one to five years); others under contract with the federal government can go up to four, six, or seven years depending on grant requirements.

Periodic state oversight of professionals does not usu-ally involve an onsite review, but random onsite reviews may be appropriate for professionals who work in their own offices. Some state regulatory bodies may have misinterpreted the survey question by indicating that the periodic oversight consists of the Legislative Sunset Review process (once every five years) for the licensing agency itself, rather than oversight of the professionals regulated by the agency; others report that there is no oversight unless there is a complaint; and some indi-cate that professional certification reviews coincide with facility inspections, which are once every five years. For a summary of survey responses regarding oversight of professionals, see Table 10, and for the single category of medical devices, Table 11.

Table 10. Required Periodic Oversight Cycle for Professionals (42 of 87 categories)

Annual 2

Other* 26

No Response 14

*Includes a 10-year cycle for internal audits; the Legislative Sunset Review process, every four years; no oversight unless there is a complaint; and professional certification reviews to coincide with facility inspections (intervals of five years).

Table 11. Required Periodic Oversight Cycle for Medical Devices (1 category)

Every one, two, or three years, depending on the inspection frequency of the device manufacturer’s radioactive materials license.

Although outside the scope of this project, it is important to better understand the nature of the oversight work completed. Some state agencies may be unable to com-ply with required oversight cycles; for some categories there may be a disconnect between oversight require-ments and the resources the agency has to comply with those requirements. It is also important to examine whether the cycles are sufficiently frequent. In addition, the qualifications and training for state staff who conduct oversight activities varies and should be examined. Also, the content of the onsite oversight review and the length of time it takes to complete the review may be impor-tant. Finally, for any particular facility it is important to be able to determine how long it has been since the facility received an onsite review.

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15Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

Facility Compliance Domains and Currency of requirements

Finding$$ The regulatory requirements for some categories of facilities and professionals are not current (in the view of the regulators).

Opportunities $$ Regulatory requirements should be updated to elimi-nate obsolete, conflicting, or irrelevant requirements, and to include new requirements if necessary.

$$ Review of regulatory requirements by a broad-based stakeholder group could reduce the potential public perception that such a review was self-serving for providers.

Health care facilities, professionals, and devices in California must meet state minimum standards as a con-dition of initial and continuing licensure, certification, registration, or other designation. While many types of facilities must comply only with state standards (e.g., congregate living health facilities, pediatric day health facilities, and respite care facilities), some categories of facilities (e.g., hospitals, skilled nursing facilities, and home health agencies) must comply with federal stan-dards as well.

Minimum standards reflect the nature of the services pro-vided. For instance, California hospitals are required to provide eight basic services in order to be state licensed, and have the option to be licensed for certain supple-mental services. Clinics that provide only outpatient services, on the other hand, do not need to meet the same minimum standards as hospitals or other facilities that provide inpatient care.

The authority to establish facility categories and state standards are written into state statutes, with a general framework and such specific requirements as the legis-lature includes. More detailed standards are established through the regulatory process. The content of specific regulations may depend on when the facility category was established. That is because regulations are influ-enced by public policy, community standards of practice,

and best operational practices, all of which tend to change over time. For example, certain surgeries used to require hospital inpatient stays but are now frequently performed on an outpatient basis. Likewise, other care and services that used to be provided in an institutional inpatient setting are now provided in facilities with a more home-like environment or in a residential setting. State statutes and associated regulations should keep pace with such dynamics within the health care delivery system.

If the facility category qualifies for participation in Medicare and Medi-Cal, an individual facility must meet specific federal CMS COPs. CMS enters into agreements with each state’s survey agency (in California, CDPH) to conduct certification work to confirm compliance with these COPs; the state has no authority to change any of these federal COPs or the conditions of the compliance reviews.

The surveys in this project asked state regulating agen-cies to report on general compliance domains in order to give a sense of what major categories state regulatory requirements include, compared with federal regulatory requirements. Some facility categories have state-only requirements, others have federal-only requirements, and some have both state and federal requirements. Table 12 (on page 16) reports on compliance domains for facilities, based on the survey responses.

It should be noted that a detailed comparative analy-sis of state and federal requirements and regulations is beyond the scope of this report. It would be extremely useful to both the state and to the facilities — but require considerable effort — if an analysis were made of the extent to which there are duplicative state and federal requirements for the same facility category, and gaps or obsolete requirements in state or federal requirements that should be addressed.

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Table 12. Compliance Domains for Facilities under State and Federal requirements (68 of 73 categories)

StAte FederAl

Administrative 31 19

Admission, Transfer, Discharge 34 17

Anesthesia Services 5 2

Assessments/Plan of Care/Treatments 46 19

Building Renovation/New Construction 28 5

Dietary Services 22 3

Disaster Preparedness/Emergency Response

25 2

Equipment and Supplies 25 18

Fire/Life Safety 24 9

Governance 36 18

Infection Control 35 9

Laboratory Services 15 7

Laundry/ Housekeeping 30 16

Medical Records 38 19

Medical Services 28 20

Nursing Services 27 16

Operational Use of Space 15 16

Optional Services 6 16

Patient/Resident/Client Rights 34 16

Pharmaceutical Services 33 18

Policies and Procedures 38 22

Quality Assurance 25 21

Radiologic Services 11 6

Staffing Levels/Requirements/Competencies

7 18

Surgery Services 6 4

Utilities, Related Mechanical Systems, and Building Maintenance

26 5

Waste Disposal 35 14

In addition to listing the domains in which they must judge compliance, survey respondents were asked to offer a subjective assessment of whether the requirements governing the categories of facilities and professionals for which they have regulatory jurisdiction are current or need to be updated. If minimum standards are not cur-rent and do not reflect the best community standards of practice, scope of practice, and changing models of health care delivery, two sets of problems result. One, the facilities may be engaging in practices that are not reviewed adequately, or at all. Two, the facilities may be engaging in compliance efforts — or seeking exemptions or waivers from them — that are outdated and therefore wasteful of both the facilities’ time, energy, and funds and those of the state, which must oversee the compliance or act on the waiver requests. And if the exceptions are not requested or the state agency lacks the authority to provide waivers, providers run the risk of being deemed deficient regarding outdated requirements.

Based on these subjective responses, as offered in Table 13, it appears that the requirements for profession-als are generally more likely to be current than are the requirements for facilities.

Table 13. regulatory requirements Considered Current

FACilitieS (68 of 73 categories)

PrOFeSSiOnAlS (42 of 87 categories)

deviCeS (1 category)

Yes 25 28 1

No 27 2 0

Partially* 9 10 0

Other 1 0 0

N/A 1 0 0

No Response 5 2 0

*Some respondents answered “Partially” to indicate that they were in the process of updating the requirements.

Note: N/A means not applicable.

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17Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

Complaints and Enforcement

Findings$$ The vast majority of state regulatory agencies have authority to investigate complaints regarding the regulated community.

$$ While termination is available as an enforcement consequence for noncompliance in almost all catego-ries of facility and professional oversight, the ability to craft lesser penalties varies considerably among categories.

Opportunities$$ Review those categories without authority to investi-gate complaints, to determine if authority should be granted under state law.

$$ Analyze availability and effectiveness of enforcement remedies for similar categories of provider in order to bring consistency to enforcement practices, and make available to state agencies the broadest appro-priate array of enforcement remedies.

If the state issues a license, certificate, registration, or other designation, using specific standards and qualifica-tions, the state can also enforce compliance with those standards. This includes the authority to investigate com-plaints filed against the regulated facility or professional, and to take remedial or punitive action.

Survey respondents in this project provided information with regard to their authority to investigate complaints, as shown in Table 14.

Table 14. authority to Investigate Complaints

FACilitieS (68 of 73 categories)

PrOFeSSiOnAlS (42 of 87 categories)

deviCeS (1 category)

65 41 1

Note: Some state regulatory programs that report the lack of authority to investigate complaints may be required to defer complaint investigations to the federal government or other entity.

Enforcement tools available to California state agen-cies (and for comparison, the federal government) for a health care facility, professional, or medical device pro-vider’s failure to comply with regulatory standards vary considerably, as shown in Table 15 (facilities), Table 16 (professionals), and Table 17 (medical devices).

Table 15. Enforcement remedies for noncompliance: Facilities (68 of 73 categories)

StAte FederAl*

Findings of Deficiencies with Plan of Correction

50 23

Fines/Monetary Penalties 39 10

More Frequent Oversight 56 20

Probation 19 0

Termination/Revocation 59 21

Temporary Suspension Order 33 3

Ban on Admissions 13 7

Ban on Payment for New Admissions 11 7

Receivership/Temporary Manager 5 7

Other† 27 3

*Not all categories have federal requirements or oversight, hence the lower numbers.

†Includes placement on an exclusion list; disapproval of a facility or county-wide plan; administrative, civil, and/or criminal penalties; onsite monitoring; directed plan of correction; findings of deficiencies; letters of admonishment; and withholding of Medi-Cal payments.

Table 16. Enforcement remedies for noncompliance: Professionals (42 of 87 categories)

StAte FederAl*

Findings of Deficiencies with Plan of Correction

19 2

Fines/Monetary Penalties 25 2

More Frequent Oversight 22 5

Probation, Proctoring, or Preceptorship

35 5

Drug Diversion Program 14 5

Termination/Revocation 41 0

Other† 22 3

*Health care professionals are less likely to be licensed under federal authority; hence, few responses in the “Federal” column.

†See Table 15 footnote.

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Table 17. Enforcement remedies for noncompliance: Medical Devices (1 category)

reSPOnSe

Findings of Deficiencies with Plan of Correction

Yes

Fines/Monetary Penalties No

More Frequent Oversight Yes

Termination/Revocation Yes

Other No

Collection and Public availability of Information

Findings$$ State programs maintain information, for various purposes, about the regulated community; some information may be made available to the public under state and federal laws.

$$ Basic information about the regulated community is not always available online.

Opportunities$$ Review the information maintained to identify more information that could be made available to the public in accordance with state and federal laws.

$$ Provide increased online public access to information about the regulated community. This could include access to basic information about licensure and certification, complaints, the nature and actual text of identified deficiencies, and enforcement actions (fines, probation, diversion, etc.).

State government agencies maintain information about the health care categories they regulate, in order to assist with administration of their oversight functions, to conduct analyses about the regulated community, and to provide information to the public. Data maintained can also track referrals made to other state agencies for instances that involve serious noncompliance.

Based on responses from the 17 General Characteristics surveys received, there are at least 89 separate databases, spreadsheets, or logs maintained by the regulating state agencies for the 68 categories of facilities, 42 categories of professionals, and 1 category of devices for which sur-vey responses were received. The types and purposes of these information sources vary, as shown in Table 18.

Table 18. Types of Content in Information Systems

nO. OF SySteMS

Basic Information (e.g., name, address, ownership, category)

72

Compliance History 39

Workload Analysis 36

Compliance Determinations, History

51

Enforcement Actions 42

Analysis of Regulated Entity 43

Referral to Other Agency, Law Enforcement, etc.

29

Consumers, payers for health care services, public policy decisionmakers, and other stakeholders have an interest in accessing basic information about regulated facilities and professionals. Where consumers have a choice or for other reasons want to know more about the places or pro-fessionals that provide their care, it is essential that this information be easily accessible, including online avail-ability. While some state programs have made significant strides in making public information about regulated health care facilities and professionals easily accessible online, others do not make even basic information about health facilities and professionals readily available.

Tables 19 and 20 show the results of survey responses from state agencies regarding information they make available, online and by other means, about regulated facilities and professionals.

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19Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

Table 19. Information available to Public, Online or Through Other Means, about Facilities (68 of 73 categories)

reSPOnSe* Online OtHer MeAnS

No Information Available Online 26 —

Names and Addresses 39 60

Surveys or Investigation Findings 9 59

Number/Types of Complaints 9 50

Final Compliance/Enforcement 12 51

Officers or Executives 5 56

Authorized Beds or Services 22 43

Expiration Date of License/Certification 23 50

Penalties and Fines 19 33

Ownership 22 57

Other† 15 16

*Not all response options are applicable to all facility categories.

†Includes other types of disciplinary actions, reference information about regulatory requirements, designated representatives, and other program-related materials.

Table 20. Information available to Public, Online or Through Other Means, about Professionals (42 of 87 categories)

reSPOnSe Online OtHer MeAnS

No Information Available Online 4 —

Names and Addresses 13 26

Survey or Investigation Findings 2 7

Number/Types of Complaints 3 7

Final Compliance/Enforcement 10 19

Expiration Date of License/Certification 33 21

Penalties and Fines 10 15

Ownership 0 1

Other* 28 14

*Includes information about other types of disciplinary actions, reference information about requirements/standards, and other program-related materials.

Communication Between Government agencies

Finding$$ Communication between state health oversight programs varies, the result of which could be a fragmented oversight process potentially leading to harm to patients, clients, or residents.

Opportunities $$ Analyze the extent to which state agencies have defined criteria for referral to other state oversight agencies, regularly implement those referral pro-cesses, and track referrals made.

$$ Establish best practices based on those state agen-cies that currently have effective referral and tracking programs for enforcement actions taken against the regulated community.

$$ Make better use of interagency agreements, delega-tion orders, and memoranda of understanding, in conjunction with referrals, data sharing, and other communication between state agencies.

With oversight responsibilities widely distributed among state agencies, effective communication between those agencies can be challenging. Meeting that challenge with effective data sharing and other regularized com-munication can result in a more efficient use of state resources and a more seamless system of oversight for the protection of the health and safety of Californians.

Ten state departments, divisions, or programs that have regulatory responsibilities within CHHS, and seven boards or committees within DCA, completed a General Characteristics Survey, for a total of 17 such surveys sub-mitted. Of those, 16 stated that they communicate with other state agencies. The nature of that communication is set out in Table 21.

Based on the list of other agencies with which state regu-latory agencies communicate (as provided in the survey responses), it appears that a portion of these commu-nications involves the investigation, processing, and prosecution of disciplinary actions taken against their regulated entities. It would seem essential for state agen-cies to communicate the results of their disciplinary or

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enforcement actions to other regulatory bodies, where those actions indicate potential for violations within other regulated categories — for example, the Medical Board of California investigating a complaint against a physician when the facts of the investigation involve that physi-cian’s performance in a hospital.

However, based on the general nature of the survey questions and responses, it cannot be confirmed that this type of interagency relationship exists on a regular basis. The important question remains whether, and if so which, state entities have criteria and tracking processes for referring the results of a completed investigation to an entity responsible for another category of licensure. If not, a complainant would also have to know to file a sep-arate complaint with the other regulatory entity in order to determine if the facility or professional had violated any of that category’s requirements. In the example of a physician’s noncompliance in a hospital setting, a com-plaint only to the entity regulating physicians could mean that the hospital’s own noncompliance might go unde-tected and potentially lead to the harm of other patients.

Further, while 16 of the 17 state regulatory agencies responded that they communicate with other agencies, only five stated that they had formal interagency agree-ments or delegation orders to define respective roles and responsibilities. None of these five involved referrals to other agencies for the purpose of sharing information that could be used by the receiving agency to consider initiation of an investigation, if warranted.

Table 21. nature and Purposes of Interagency Communication (17 responding agencies)

Verify Information 16

Share Enforcement Actions* 13

Operational Issues in Common 12

Policy Issues in Common 12

Share Data 10

Other† 3

*Involving the investigation, processing, and/or prosecution of disciplinary actions taken against their own regulated entities.

†Includes assisting other agencies with exemption requests and sharing website licensure and enforcement data.

Of the 16 state regulatory agencies that responded to questions about communication with other state agen-cies, 13 reported that they communicate investigation, enforcement, or compliance information about their regulated entities to other state departments only on an as-needed basis, and 11 reported that their communi-cation with other state agencies is restricted to specific regulated entities.

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21Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

appendix a. State-regulated Categories of Health Care Facilities and ProfessionalsThe following chart provides a list of the categories of health care-related facilities, designations, and professionals in California that are regulated by state agencies. (Designation refers to approval given to a facility to provide specific services, separate from any license for the facility; some designations may be given to facilities not licensed by the des-ignating agency.) The chart arranges the categories under the California Health and Human Service Agency departments and the Business, Consumer Services, and Housing Agency, Department of Consumer Affairs, boards and committees responsible for their regulation and oversight.

Note: The number in brackets indicates the number of facilities or professionals within the category. Categories without a number indicate that the regulating board, committee, or other agency did not respond to the invitation to complete a survey.

FACilitieS Or deSignAtiOnS regulAted PrOFeSSiOnAlS regulAted

California Health and Human Services agency

California department of Aging

CBAS [260: 246 open, 16 closed and in suspense]

California department of Public Health*

$$ Acute Psychiatric Hospital [38]

$$ Adult Day Health Center [300]

$$ Alternative Birthing Centers [8]

$$ Ambulatory Surgical Centers [771]

$$ Biologics License [220]

$$ Certificate of Registration/Licenses (Laboratory) [14,974]

$$ Certificate of Registration (Radiologic) [approx. 30,000]

$$ Chemical Dependency Recovery Hospital [6]

$$ Chronic Dialysis Clinics [4 licensed only, 571 licensed and certified as ESRD]

$$ Community Clinic [1,127]

$$ Comprehensive Outpatient Rehabilitation Facility [3]

$$ Congregate Living Health Facility (A, B, & C) [55]

$$ Correctional Treatment Centers [19]

$$ Critical Access Hospital [31]

$$ Drug Manufacturer License [453]

$$ End Stage Renal Dialysis [567]

$$ Federally Qualified Health Center or FQHC Look-alike

$$ Free Clinic [43]

$$ General Acute Care Hospital [437]

$$ Home Health Agency [1,451]

$$ Home Medical Device Retail [1,331]

$$ Hospice [435]

$$ Hospice Facility [1]

$$ Intermediate Care Facility [5]

$$ Intermediate Care Facility/Developmentally Disabled [10]

$$ Bioanalyst [48]

$$ Certified Hemodialysis Technician [5,676]

$$ Certified Home Health Aide [49,172]

$$ Certified Industrial Radiographer [unknown]†

$$ Certified Nuclear Medicine Technologist [2,229]

$$ Certified Nursing Assistant [163,658]

$$ Certified Radiologic Technologist [24,952]

$$ Certified Supervisor/Operator (Radiologic) [23,859]

$$ Clinical Laboratory Scientist [16,589]

$$ Clinical Laboratory Scientist (Limited) and Cytotechnologist [2,582]

$$ Director License (Laboratory) [167]

$$ Genetic Counselor [464]

$$ Home Medical Device Retail Exemptee [2,806]

$$ Limited Permit X-Ray Technician [4,602]

$$ Medical Laboratory Technician [280]

$$ Medical Physicist [562]

$$ Nursing Home Administrator [2,045]

$$ Occupational Therapist in Independent Practice/Physical Therapist in Independent Practice/Speech Therapist [84]

$$ Phlebotomist [approx. 36,000]

$$ Public Health Microbiologist [1,885]

$$ Sickle Cell Anemia Counselor [4]

$$ Trainee (Laboratory) [1,086]

*In addition to regulating facilities and professionals, the CDPH regulates medical devices that contain a radiologic source: Source and Device Registry (80). †Requires certification by other entity but does not directly issue certificate.

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Facilities or Designations regulateD ProFessionals regulateD

california Department of Public Health,* continued

$$ Intermediate Care Facility/Developmentally Disabled/Habilitative [760]

$$ Intermediate Care Facility/Developmentally Disabled/Nursing [419]

$$ Medical Device Manufacturers License [1,333]

$$ Pediatric Day Health and Respite Care Facility [16]

$$ Prenatal Diagnostic Center [139]

$$ Private Duty Nursing Agency [0]

$$ Psychology Clinic [25]

$$ Radioactive Materials License [approx. 1,800]

$$ Referral Agency [6]

$$ Rehabilitation Clinic [16]

$$ Rural Health Clinic [271]

$$ Skilled Nursing Facility [1,287]

$$ Specialty Hospital [0]

$$ Surgical Clinic [37]

$$ Tissue Bank [646]

Department of Health care services

$$ Alcoholism or Drug Abuse Recovery or Treatment Facility [1,357]

$$ County Designated Facility Under LPS Act for W&I Code §5150 [159]

$$ California Children’s Services (CCS) Approval for Hospitals, PICU/NICU, and Special Care Centers That Meet CCS Standards Requirements [820]

$$ Driving Under the Influence Program [500]

$$ Narcotic Treatment Program [156]

$$ Mental Health Rehabilitation Center [20]

$$ Program for All-Inclusive Care for the Elderly [7]

$$ Psychiatric Health Facility [24]

$$ Residential Alcoholism or Drug Abuse Recovery or Treatment Facility [802]

$$ Alcohol and Other Drug (AOD) Counselor [approx. 36,000]

$$ California Children’s Services Approval for Doctors and Allied Health Professionals [unknown]

Department of social services

$$ Adult Residential Facility [5,159]

$$ Adult Residential Facility for Persons with Special Needs [26]

$$ Community Treatment Facility [2]

$$ Residential Care Facility for the Chronically Ill [19]

$$ Residential Care Facility for the Elderly [7,497]

$$ Small Family Home [183]

$$ Social Rehabilitation Facility [26]

$$ Residential Care Facility for the Elderly, Administrator

emergency Medical services authority

$$ Ambulance and Air Ambulance Zones [338]

$$ Trauma System and Trauma Center Designation (Hospital) [73]

$$ Advanced Emergency Medical Technician [93]

$$ Emergency Medical Technician [approx. 59,000]

$$ Paramedic [approx. 20,000]

office of statewide Health Planning and Development

$$ OSHPD-3 Clinic (Building Construction Permit, Certificate of Occupancy, Certification of Compliance) [varies]

$$ Seismic Standard Compliance [unknown]

$$ Hospital Inspector Certification [Class A: 848; Class B: 68; Class C: 96]

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23Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

FACilitieS Or deSignAtiOnS regulAted PrOFeSSiOnAlS regulAted

Business, Consumer Services, and Housing agency

Department of Consumer affairs

Acupuncture Board $$ Acupuncturist

Board of Behavioral Sciences

$$ Associate Clinical Social Worker

$$ Licensed Clinical Social Worker

$$ Licensed Marriage and Family Counselor

$$ Marriage and Family Therapist, Intern

$$ Professional Clinic Counselor Intern

Board of Chiropractic examiners

$$ Chiropractic License

Board of Occupational therapy

$$ Occupational Therapist

$$ Occupational Therapy Assistant

Board of Optometry $$ Optometric Practice Branch Office $$ Optometrist

$$ Open Angle Glaucoma Certification

$$ Lacrimal Irrigation and Dilation Certification

$$ Therapeutic Pharmaceutical Agent Certification

Board of Pharmacy $$ Centralized Packaging Hospital Pharmacy [0]

$$ Clinic Pharmacy [1,352]

$$ Hospital Pharmacy [584]

$$ Hypodermic Needle and Syringe [355]

$$ Injectable Sterile Compounding [273]

$$ Injectable Sterile Compounding Pharmacy Located Outside California, Shipping to California [93]

$$ Pharmacy [6,375]

$$ Pharmacy Located Outside California, Shipping to California [482]

$$ Veterinary Food/Drug Retailer [27]

$$ Wholesaler [625]

$$ Wholesaler Located Outside California, Shipping to California [807]

$$ Pharmacist [39,791]

$$ Pharmacist Intern [5,823]

$$ Pharmacy Technician [73,890]

Board of Podiatric Medicine

$$ Doctor of Podiatric Medicine

Board of Psychology $$ Psychological Assistant

$$ Psychologist

$$ Registered Psychologist

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24California HealthCare Foundation

FACilitieS Or deSignAtiOnS regulAted PrOFeSSiOnAlS regulAted

Board of registered nursing

$$ Clinical Nurse Specialist

$$ Nurse Anesthetist

$$ Nurse Midwife

$$ Nurse Practitioner

$$ Psychiatric/Mental Health Nurse Specialist

$$ Public Health Nurse

$$ Registered Nurse

Board of vocational nursing and Psychiatric technician

$$ Psychiatric Technician

$$ Vocational Nurse

dental Board of California

$$ Dentist [45,346]

$$ Oral and Maxillofacial Surgery Permit [83]

dental Hygiene Committee of California

$$ Registered Dental Hygienist

$$ Registered Dental Hygienist in Alternative Practice

Medical Board of California

$$ Midwife [270]

$$ Physician and Surgeon [126,483]

$$ Registered Contact Lens Dispenser [948]

$$ Registered Dispensing Optician [1,170]

$$ Registered Nonresident Contact Lens Seller [10]

$$ Registered Polysomnographic Trainee, Technician, and Technologist [0]

$$ Registered Research Psychoanalyst and Student Research Psychoanalyst [87]

$$ Registered Spectacle Dispenser [2,258]

naturopathic Medicine Committee

$$ Naturopathic Doctor [589]

Osteopathic Medical Board of California

$$ Osteopathic Physician and Surgeon

Physician Assistant Board

$$ Physician Assistant

Physical therapy Board of California

$$ Electromyographer Certification

$$ Physical Therapy [40,189]

$$ Physical Therapist Assistant [10,113]

respiratory Care Board

$$ Respiratory Care Practitioner [21,473]

Speech-language Pathology and Audiology and Hearing Aid dispensers Board

$$ Audiologist

$$ Dispensing Audiologist

$$ Hearing Aid Dispenser

$$ Speech-Language Assistant

$$ Speech-Language Pathologist

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25Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

appendix B. Profiles of State Health Care regulatory BodiesThe following is a profile of the departments, boards, committees, and other agencies under the state Health and Human Services Agency and the Business, Consumer Services, and Housing Agency, Department of Consumer Affairs, respon-sible for regulation and oversight of health care–related facilities, designations, professionals, and medical devices. The profiles include those agencies that did not respond to this project’s survey request.

provided leadership and coordination in the planning, development, implementation, and evaluation of a com-prehensive system of statewide alcohol and drug use prevention, intervention, detoxification, treatment, and recovery. Statewide, the treatment, recovery, and pre-vention network consists of over 850 public and private community-based providers which serve approximately 300,000 clients annually.

After 35 years as a freestanding department, effective July 1, 2013 ADP ceased operations and transferred its licensing and certification functions to the Department of Health Care Services (DHCS).

For contact information and website addresses for the various licensing and certification responsibilities for-merly under ADP, refer to the Substance Use Disorder Services website under DHCS: www.dhcs.ca.gov.

California Department of Public HealthThe mission of the California Department of Public Health (CDPH) is to:

$$ Promote healthy lifestyles for individuals and families in their communities and workplaces

$$ Prevent disease, disability, and premature death, and reduce or eliminate health disparities

$$ Protect the public from unhealthy and unsafe environments

$$ Provide or ensure access to quality, population-based health services

$$ Prepare for and respond to public health emergencies

$$ Produce and disseminate data to inform and evaluate public health status, strategies, and programs

CDPH has responsibility for regulating a large number of facilities and sites where Californians receive health care, contact health care professionals, and access medical devices.

HeAltH And HuMAn ServiCeS AgenCy California Department of agingThe California Department of Aging (CDA) administers programs that serve older adults, adults with disabilities, family caregivers, and residents in long term care facili-ties. CDA administers funds allocated under the federal Older Americans Act, the Older Californians Act, and Medi-Cal.

CDA contracts with the network of Area Agencies on Aging, which directly manages a wide array of federal and state-funded services that help older adults find employment, support older and disabled individuals to live independently in the community, promote healthy aging and community involvement, and assist care-giver family members. CDA also contracts directly with agencies that operate the Multipurpose Senior Services Program, through the Medi-Cal home and community-based waiver for the elderly, and certifies Adult Day Health Care centers for participation as Community-Based Adult Services (CBAS) providers under Medi-Cal.

California Department of Aging1300 National Drive, Suite 200Sacramento, CA 95834-1992(916) 419-7500www.aging.ca.gov

For more information about CBAS certification: www.aging.ca.gov.

Department of alcohol and Drug ProgramsThe Department of Alcohol and Drug Programs (ADP) was designated the “single state agency” responsible for administering and coordinating the state’s efforts in alco-hol and drug abuse prevention, treatment, and recovery services. ADP was also the primary state agency respon-sible for interagency coordination of these services.

In partnership with California’s 58 county alcohol and drug programs and in cooperation with numerous private and public agencies, organizations, and individuals, ADP

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26California HealthCare Foundation

Physical Address:

California Department of Public Health1615 Capitol AvenueSacramento, CA 95814-5015

Note: Various offices are located throughout the state; see website for details.

Mailing Address:

PO Box 997377, MS 0500Sacramento, CA 95899-7377(916) 558-1784www.cdph.ca.gov

Food and Drug Branch, Drug Safety Program

1500 Capitol Avenue, MS 7602PO Box 997435Sacramento, CA 95899-7435(916) 650-6500Consumer Complaints (Drug Products): (800) 495-3232email: [email protected]

Genetic Disease Screening Program

Program Standards and Quality Assurance Branch850 Marina Bay Parkway, F-175Richmond, CA 94804(510) 412-1502email: [email protected]

Laboratory Field Services

LFS Northern California Office 850 Marina Bay Parkway, Building P, 1st FloorRichmond, CA 94804(510) 620-3800

LFS Southern California Office320 West Fourth Street, Suite 890Los Angeles, CA 90013 (213) 620-6160 email: [email protected]

Licensing and Certification Program

PO Box 997377, MS 3000Sacramento, California 95899-7377(916) 552-8700 or (800) 236-9747 (toll free) www.cdph.ca.gov

Complaints

For questions or complaints about hospitals, hospice, health care facilities, or nursing homes, contact the local CDPH Licensing and Certification District Office:

Bakersfield: (866) 222-1903Chico: (800) 554-0350East Bay: (866) 247-9100Fresno: (800) 554-0351Los Angeles: (800) 228-1019Orange County: (800) 228-5234Riverside: (888) 354-9203Sacramento: (800) 554-0354San Bernardino: (800) 344-2896San Diego (North): (800) 824-0613San Diego (South): (866) 706-0759San Francisco: (800) 554-0353San Jose: (800) 554-0348Santa Rosa: (866) 784-0703Ventura: (800) 547-8267

Aide and Technician Certification

For information regarding certification as a Certified Nurse Assistant (CNA), Home Health Aide (HHA), or Certified Hemodialysis Technician (CHT), or to lodge a complaint, contact the Aide and Technician Certification Section (ATCS), CNA/HHA/CHT Certification Unit.

ATCS, Certification UnitPO Box 997416, MS 3301Sacramento, CA 95899-7377(916) 327-2445 Message Center (voicemail): (916) 552-8811 Complaints: (916) 492-8232email: [email protected]

For information regarding the certification status of other provider types, obtain the correct phone number from this list of CDPH programs: www.cdph.ca.gov.

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27Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

Radiologic Health Branch

Mailing Address:

PO Box 997414, MS 7610Sacramento, CA 95899-7414

Physical Address:

1500 Capitol Avenue, Fifth Floor, MS 7610Sacramento, CA 95814-5006(916) 327-5106www.cdph.ca.gov

California Department of Social ServicesThe mission of the California Department of Social Services is to serve, aid, and protect needy and vulner-able children and adults.

Community Care Licensing Division

The Community Care Facilities Act, administered by the Department of Health, established a statewide system of community care, separate from health care, for persons with mental and developmental disabilities, and socially dependent children and adults. The Department of Health, together with care providers under the Advisory Committee on Community Care Facilities, jointly estab-lished regulations for licensing nonmedical out-of-home care facilities.

Community care was originally envisioned as a normaliz-ing and least restrictive environment for people needing basic care and supervision that would assist them in performance of the activities of daily living. The chil-dren and adults placed in such settings were envisioned as requiring little more than a healthful, safe, and sup-portive environment. Community care now also includes care for persons whose needs require the management of severe behavior adjustment problems, serious mental disorders, and significant medical conditions. In order to give emphasis to the different populations served, the Community Care Licensing Program is now governed by three separate licensing acts and a fourth statute that was enacted in 1990.

744 P StreetSacramento, CA 95814(916) 651-8848www.cdss.ca.gov

Adult and Senior Care Program:

744 P Street, MS 8-3-90Sacramento, California 95814(916) 657-2592

Children’s Residential Program:

744 P Street, MS 8-3-54Sacramento, CA 95814(916) 651-5380

For more information about the Community Care Licensing Division, visit www.ccld.ca.gov.

Department of Health Care ServicesThe Department of Health Care Services (DHCS) works closely with health care professionals, county govern-ments, and health plans to provide a health care safety net for California’s low-income population and persons with disabilities. DHCS finances and administers a num-ber of individual health care service delivery programs including the California Medical Assistance Program (Medi-Cal), California Children’s Services, Child Health and Disability Prevention, and Genetically Handicapped Persons Program. Also, effective July 1, 2013, the over-sight functions and authority of the Department of Alcohol and Drug Programs over substance use disorder services, as well as mental health rehabilitation and psy-chiatric health facilities under the Department of Social Services, have been transferred DHCS. DHCS also helps maintain the financial viability of critical specialized care services such as burn centers, trauma centers, and chil-dren’s specialty hospitals. In addition, DHCS funding helps hospitals and clinics located in underserved areas and those serving underserved populations.

General Information:

(916) 445-4171

California Children’s Services, Systems of Care Division:

www.dhcs.ca.gov

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Long Term Care Division:

PO Box 997413, MS 0018Sacramento, CA 95899-7413(916) 552-9105

For more information about PACE and the Long Term Care Division visit www.dhcs.ca.gov.

Emergency Medical Services authorityThe Emergency Medical Services Authority (EMSA) is charged with providing leadership in developing and implementing EMS systems throughout California and setting standards for the training and scope of prac-tice of various levels of EMS personnel. EMSA also has responsibility for promoting disaster medical prepared-ness throughout the state and, when required, managing the state’s medical response to major disasters.

EMSA oversees the first responders, EMTs, nurses, physi-cians, and administrators who deliver care to the public and operate the emergency care system. Day-to-day EMS system management is the responsibility of local and regional EMS agencies. EMSA staff work closely with many local, state, and federal agencies and private enter-prises with emergency and/or disaster medical services roles and responsibilities.

Emergency Medical Services Authority10901 Gold Center Drive, Suite 300Rancho Cordova, CA 95670(916) 332-4336Paramedic Program: (916) 323-9875www.emsa.ca.gov

Office of Statewide Health Planning and DevelopmentThe Office of Statewide Health Planning and Development (OSHPD) provides the state with enhanced understanding of the structure and function of its health care delivery systems. OSHPD’s role also includes direct delivery of various services to promote health care acces-sibility. OSHPD collects and disseminates information about California’s health care infrastructure and health care outcomes, and promotes an equitably distributed health care workforce. OSHPD also monitors the con-struction, renovation, and seismic safety of hospitals and skilled nursing facilities and provides loan insurance to facilitate the capital needs of California’s nonprofit health care facilities.

General OSHPD Information

400 R StreetSacramento, CA 95811-6213www.oshpd.ca.gov

Facilities Development Division

Sacramento Office, Headquarters400 R Street, Suite 200Sacramento, CA 95811-6213Deputy Director: (916) 440-8381Deputy Division Chief: (916) 440-8372www.oshpd.ca.gov/FDD

Los Angeles Office700 N. Alameda Street, Suite 2-500Los Angeles, CA 90012(213) 897-0166

BuSineSS, COnSuMer ServiCeS, And HOuSing AgenCy, dePArtMent OF COnSuMer AFFAirSThe mission of the Department of Consumer Affairs (DCA) is to protect and serve California consumers while ensur-ing a competent and fair marketplace. The DCA issues licenses in more than 100 business and 200 professional categories, including doctors and dentists. The DCA includes 36 regulatory bodies (23 boards, six bureaus, four committees, two programs, and one commission) that establish minimum qualifications and levels of com-petency for licensure. They also investigate complaints and discipline violators. The committees, commission, and boards are semiautonomous bodies whose mem-bers are appointed by the governor and the legislature. DCA provides them administrative support. DCA’s opera-tions are funded exclusively by license fees.

Consumer Assistance

Department of Consumer AffairsConsumer Information Division1625 North Market Boulevard, Suite N 112Sacramento, CA 95834(916) 445-1254 or (800) 952-5210 (toll free)www.dca.ca.gov

To reach a specific regulatory board or other DCA entity, see listings below.

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29Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

acupuncture BoardThe Acupuncture Board licenses and regulates acupunc-turists. The board administers a qualifying examination, issues licenses, approves and monitors students in tutorial programs, approves acupuncture schools and continu-ing education providers and courses, and enforces the Acupuncture Licensure Act. The board is comprised of seven members: four members of the public and three licensed acupuncturists.

1747 N. Market Boulevard, Suite 180Sacramento, CA 95834(916) 515-5200email: [email protected]

Board of Behavioral ScienceThe Board of Behavioral Science regulates Licensed Marriage and Family Therapists, Licensed Clinical Social Workers, Licensed Educational Psychologists, Licensed Professional Clinical Counselors, MFT Interns, Associate Clinical Social Workers, and Professional Clinical Counselor Interns.

Board of Behavioral Sciences1625 N. Market Boulevard, Suite S-200Sacramento, CA 95834(916) 574-7830email: [email protected]

California Board of Occupational TherapyThe California Board of Occupational Therapy is respon-sible for the licensure and regulation of Occupational Therapists (OT) and Occupational Therapy Assistants (OTA). Enforcement Program representatives assist with filing a complaint against an OT or OTA, provide copies of public documents, and answer questions pertaining to the enforcement process or disciplinary action taken against a licensee.

2005 Evergreen Street, Suite 2050Sacramento, CA 95815(916) 263-2294email: [email protected]

For licensing, renewal, and advance practice questions, email: [email protected].

California Board of OptometryThe California Board of Optometry licenses and regulates the profession of optometry, including Optometrists, Open Angle Glaucoma Certification, Lacrimal Irrigation and Dilation Certification, Therapeutic Pharmaceutical Agent Certification, and Optometric Practice Branch Offices.

2450 Del Paso Road, Suite 105Sacramento, CA 95834(916) 575-7170 or (866) 585-2666 (toll free)email: [email protected]

Board of PharmacyThe Board of Pharmacy oversees the quality of pharma-cists’ care and the appropriate use of pharmaceuticals through education, communication, licensing, legislation, regulation, and enforcement. The board’s responsibilities include licensure for pharmacists, pharmacist interns, pharmacy technicians, pharmacies, centralized pack-aging hospital pharmacies, clinic pharmacies, hospital pharmacies, hypodermic needle and syringe providers, injectable sterile compounding providers, injectable ster-ile compounding located outside California and shipping into California, pharmacies located outside California and shipping into California, and veterinary food/drug retailers.

1625 North Market Boulevard, Suite N219Sacramento, CA 95834(916) 574-7900www.pharmacy.ca.gov

Board of registered nursingThe Board of Registered Nursing (BRN) regulates the practice of registered nurses. The BRN issues certificates to eligible public health nurses, nurse practitioners, nurse anesthetists, nurse midwives, and clinical nurse special-ists. The BRN also maintains a list of eligible psychiatric/mental health nurse specialists.

Physical Address:

1747 North Market Boulevard, Suite 150 Sacramento, CA 95834

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BRN Mailing Address:

PO Box 944210Sacramento, CA 94244-2100(916) 322-3350www.rn.ca.gov

Board of Chiropractic ExaminersThe Board of Chiropractic Examiners regulates the chiro-practic profession. The board is responsible for licensing, continuing education, enforcement, administration, and other regulatory responsibilities.

901 P Street, Suite 142ASacramento, California 95814(916) 263-5355www.chiro.ca.gov

Dental Hygiene Committee of CaliforniaThe responsibilities of the Dental Hygiene Committee of California include issuing, reviewing, and revoking licenses; developing and administering examinations; adopting regulations; and determining fees and con-tinuing education requirements for registered dental hygienists and registered dental hygienists in alternative practice.

2005 Evergreen Street, Suite 1050 Sacramento, CA 95815(916) 263-1978www.dhcc.ca.gov

Board of Licensed Vocational nursing and Psychiatric TechniciansThis board is responsible for administering the laws related to the practice of licensed vocational nurses and psychiatric technicians.

2535 Capitol Oaks Drive, Suite 205Sacramento, CA 95833(916) 263-7800 email: [email protected]

The Medical Board of CaliforniaThe Medical Board of California licenses and regulates physicians, surgeons, and certain allied health care pro-fessionals, and enforces the Medical Practice Act.

2005 Evergreen Street, Suite 1200Sacramento, CA 95815www.mbc.ca.gov

Board of Podiatric MedicineDoctors of Podiatric Medicine are specialists in the foot and ankle. The Board of Podiatric Medicine administers their licensing under the Medical Practice Act.

2005 Evergreen Street, Suite 1300Sacramento, CA 95815(916) 263-2647 email: [email protected] www.bpm.ca.gov

Physician assistant BoardThe Physician Assistant Board oversees licensing and education of physician assistants and enforces related laws and regulations.

2005 Evergreen Street, Suite 1100 Sacramento, CA 95815(916) 561-8780email: [email protected]

registered Dispensing Optician ProgramThe Registered Dispensing Optician Program regulates professionals engaged in optical dispensing and is com-prised of four sections: Registered Dispensing Opticians (business location), Spectacle Lens Dispensers, Contact Lens Dispensers, and Nonresident Contact Lens Sellers.

Medical Board of CaliforniaAttn: RDO Program2005 Evergreen Street, Suite 1200Sacramento, CA 95815(916) 263-2382email: [email protected]

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31Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

registered Polysomnographic ProgramThe Registered Polysomnographic Program regulates the professionals engaged in the treatment, manage-ment, diagnostic testing, control, education, and care of patients with sleep and wake disorders. The program registers individuals as polysomnographic trainees, tech-nicians, and technologists.

Medical Board of CaliforniaAttn: Registered Polysomnographic Program2005 Evergreen Street, Suite 1200Sacramento, CA 95815(916) 263-2382email: [email protected]

Osteopathic Medical Board of CaliforniaThe Osteopathic Medical Board of California licenses osteopathic physicians and surgeons, oversees con-tinuing education requirements, investigates consumer complaints, and uses its enforcement powers to ensure practitioners abide by the provisions of the state Business and Professions Code/Medical Practice Act.

1300 National Drive, Suite 150Sacramento, CA 95834-1991(916) 928-8390 email: [email protected] www.ombc.ca.gov

naturopathic Medicine CommitteeThe Naturopathic Medicine Committee, funded by appli-cation and licensing fees, is responsible for answering public inquiries; issuing licenses; coordinating legislative, regulatory, and budgetary activities; preparing reports; and administering disciplinary and enforcement activities.

(916) 928-4785email: [email protected]

Physical Therapy Board of CaliforniaThe Physical Therapy Board of California administers and enforces the Physical Therapy Practice Act, licens-ing, regulating, and disciplining physical therapists and physical therapist assistants. The board consists of seven members (four licensed physical therapists and three public members).

2005 Evergreen Street, Suite 1350Sacramento, CA 95815(916) 561-8200 www.ptbc.ca.gov

respiratory Care Board of CaliforniaLicensed Respiratory Care Practitioners (RCP) perform lifesaving and life support procedures as prescribed by physicians. RCPs provide care directly to the patient in either a hospital setting or the patient’s home. The Respiratory Care Board regulates RCPs and administers and enforces the Respiratory Care Practice Act.

3750 Rosin Court, Suite 100Sacramento, CA 95834Phone: (916) 999-2190Toll-free: (866) 375-0386email: [email protected]

Speech-Language Pathology and audiology and Hearing aid Dispensers BoardThe Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board ensures the qualifications and competency of providers of speech-language pathol-ogy, audiology, and hearing aid dispensing services. The board promulgates laws and regulations; issues, renews, suspends, and revokes licenses; and imposes disciplinary actions.

SLPAHADB2005 Evergreen Street, Suite 2100Sacramento, CA 95815Phone: (916) 263-2666email: [email protected]

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32California HealthCare Foundation

appendix C. Project Methodology The depth and breadth of state regulatory oversight of the facilities where Californians get health care services, of the professionals who provide services at those facili-ties and elsewhere, and of the medical devices used, is extensive. These responsibilities are shared among mul-tiple state agencies, departments, board, bureaus, and commissions.

Most of these agencies have a long history of regulating some aspect of health care service delivery. However, the approach to regulatory oversight, the scope of author-ity, and other oversight characteristics can vary among these agencies, depending on the political and business climate at the time the responsibilities were first estab-lished and subsequent issues, problems, information, and media coverage regarding the regulated entities.

For this project, the following methodology was used to gather information about the current landscape of state government regulatory oversight responsibilities for health care delivery.

Preliminary Identification of State Government agencies and regulated CommunitiesPreliminary identification of the state departments, boards, bureaus, and commissions that have oversight responsibilities for regulating facilities, professionals, and medical devices was first accomplished through an Internet search of state government websites. Once these state agencies were identified, there was further review of the websites regarding the specific category of licenses, certificates, registrations, or other designations issued by each entity. Each state government agency was then asked to verify the list of regulated entities for which they are responsible.

Data Collection/Survey ToolsDespite differences in the ways state agencies perform their regulatory duties, data collection for the project began with design of a basic, common framework. This was accomplished through each participating state agen-cy’s completion of a survey for each category of facility, profession, or device regulated. In addition, each par-ticipating state agency was asked to complete a General Characteristics survey for its entire program.

The survey used an Excel spreadsheet format and con-tained four parts. Participating agencies reported that each survey part took an average of 15 minutes to

complete. The four surveys may be found at the conclu-sion of this appendix.

$$ General Characteristics Survey. One of these surveys was completed per program, board, bureau, or commission. This survey was designed to gather information about:

$$ Data maintained and information collected about the regulated entity

$$ Communication and coordination between state government agencies about the regulated entity

$$ Facilities Survey, Professionals Survey, and Medical Devices Survey. One survey was completed for each category of facilities/places/sites, professionals, and medical devices. These surveys were designed to gather information about:

$$ Number and types of licenses, certificates, registrations, or other designations issued

$$ Funding sources to support regulatory oversight functions

$$ Applications, renewal, and fees

$$ Standards, compliance, and intensity of oversight

$$ Complaints and enforcement

$$ Public availability of data/information

$$ Statutory and regulatory authority

$$ Website addresses/links

Inventory and analysis of State Government approaches to regulating Facilities, Professionals, and DevicesBased on the survey responses, an inventory of the regu-lated entities was completed, and various comparative analyses of the major data components contained in the survey were conducted. Major findings from the inven-tory and analysis were included in this report. In addition, high-level opportunities to improve the effectiveness and efficiency of state government oversight of the regulated entities were identified and included.

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33Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

Interviews with Key Thought Leaders Selected state health care thought leaders were invited to share their experiences and perspectives about the state health care regulatory framework. These thought leaders represented a broad spectrum of individuals with significant experience of work within the health care delivery system. The thought leaders who participated in this project are:

$$ William Barcellona, senior vice president, govern-ment affairs, California Association of Physicians Groups

$$ Carmela Castellano-Garcia, CEO and president, California Primary Care Association

$$ Robert Edmundson, CEO, On Lok, and president, CalPACE

$$ Jim Gomez, CEO and president, California Association of Health Facilities

$$ Sally Michaels, CEO, and Heather Harrison, vice pres-ident, governmental/regulatory relations, California Assisted Living Association

$$ Mitch Katz, MD, director, Los Angeles Department of Health Services

$$ Kathleen Kelly, executive director, Family Caregiver Alliance/National Center for Caregivers

$$ Jon Roth, CEO and Brian Warren, director, govern-ment and professional affairs, California Pharmacists Association

State Government regulatory agencies That Participated in This Project Not all state agencies contacted for this project partici-pated in it. Almost all departments within the California Health and Human Services Agency completed the surveys provided them by the project. A much smaller percentage participated of the departments and boards within the Business, Consumer Services, and Housing Agency, Department of Consumer Affairs. The regulatory agencies that participated were:

California Health and Human Services agency

$$ California Department of Aging

$$ California Department of Public Health

$$ Food and Drug Branch, Drug Safety Program

$$ Genetic Disease Screening Program

$$ Laboratory Field Services

$$ Licensing and Certification Program

$$ Radiologic Health Branch

$$ Department of Alcohol and Drug Programs (now under the Department of Health Care Services)

$$ Department of Health Care Services

$$ Long-Term Care Division

$$ Systems of Care Division, California Children’s Services

$$ Department of Social Services

$$ Community Care Licensing

$$ Emergency Medical Services Authority

$$ Office of Statewide Health Planning and Development

$$ Health Facilities Division

Business, Consumer Services, and Housing agency

$$ Department of Consumer Affairs

$$ Dental Board of California

$$ Medical Board of California

$$ Naturopathic Medicine Committee

$$ Board of Pharmacy

$$ Physical Therapy Board of California

$$ Respiratory Care Board

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State Government regulatory agencies That Did not respond to This Project or Did not Complete SurveysFewer than half of the regulatory boards and commis-sions of the Business, Consumer Services, and Housing Agency responded to invitations to participate in this project or responded but did not complete the project’s surveys. These agencies almost all regulate categories of health care professionals. As a result of their failure to participate, the data the project collected about profes-sionals are considerably less complete than the data for facilities. The agencies that did not participate are:

Business, Consumer Services, and Housing agency

$$ Department of Consumer Affairs

$$ Acupuncture Board

$$ Board of Behavioral Sciences

$$ Board of Chiropractic Examiners

$$ Dental Hygiene Committee

$$ Board of Occupational Therapy

$$ Board of Optometry

$$ Osteopathic Medical Board

$$ Physician Assistant Board

$$ Board of Podiatric Medicine

$$ Board of Psychology

$$ Board of Registered Nursing

$$ Speech-Language Pathology, Audiology, and Hearing Aid Dispensers Board

$$ Board of Vocational Nursing and Psychiatric Technicians

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35Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

1.Agency

DepartmentDivision/Board/Bureau

Branch/Committee/Section

2. Please provide your contact information.Name and Title

Telephone NumberE-mail Address

1.

State training and/or testingFederal training and/or testingProfessional Degrees and/or LicensesOther (Please Specify)Other (Please Specify)Other (Please Specify)

1.

Information System 1

Information System 2

Information System 3

Information System 4

Information System 5

Information System 6

Information System 7

Information System 8

General Oversight Characteristics(All departments, programs, boards or bureaus complete this section once)

Section A. Identifying Information

Section C. Data Systems/Information/Spreadsheets/Logs, etc. Maintained for Regulatory Oversight

Section B. General Oversight Characteristics

What Department, Program, Division, Branch, Board and/or Bureau do you represent?

Does the oversight function require staff with specialized skills or screening (other than civil service exams)?

Please provide a list/name of all data, information systems, tracking sheets and/or spreadsheets used to support the regulatory oversight for the program, branch, board or bureau. (exclude administrative systems, such as budgets, personnel, timekeeping, etc.)

Select all that Apply

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36California HealthCare Foundation

4.

5.

6. Do you have any other formal mechanism for coordinating oversight responsibilities with other state agencies?

Other agency access to databasesWork group or other established interagency meetingsOther (Specify)

Is this communication between state agencies restricted to specific regulated entities?

Do you have delegation orders or interagency agreements with other state agencies that outline roles and responsibilities of each agency, and that deal with regulated entities? If so, please provide a copy of the delegation order, or a summary that clearly outlines the respective roles and responsibilities (collected outside spreadsheet)

if yes, please list the regulated entities affected:

Select all that Apply

2. What are the purposes of these systems?

System 1 System 2 System 3 System 4

N/A

Compliance History Workload Analysis Compliance Determinations, History Enforcement Actions Analysis of regulated entity

Referral to other agency, law enforcement, etc. Other (specify)

Other (specify)

Other (specify)

System 5 System 6 System 7 System 8

N/A

Compliance History Workload Analysis Compliance Determinations, History Enforcement Actions Analysis of regulated entity

Referral to other agency, law enforcement, etc. Other (specify)

Other (specify)

Other (specify)

1.

Verify informationShare enforcement actionsOperational issues in commonPolicy issues in commonShare dataOther (please specify)

2. If yes, please specify what state departments or programs you communicate with.

3.

Section D. Communications between State Governmental EntitiesDo you communicate information about the regulated entities to other state departments or other programswithin your department? If yes, please select the nature of the communication.

Do you communicate investigations/enforcement/compliance information about the regulated entities to other state departments on an as-needed basis?

if yes, please specify the other state departments:

Basic information about regulated entity for license, certificate, or registration & renewal (name, address, ownership, category, etc.)

Basic information about regulated entity for license, certificate, or registration & renewal (name, address, ownership, category, etc.)

Select all that Apply

Select all that Apply

Select all that Apply

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37Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

1.Agency

DepartmentDivision/Board/Bureau

Branch/Committee/Section

2. Please provide your contact information.Name and Title

Telephone NumberE-mail Address

3a. What is the name of the license, certificate, registration, or other designation for the device or piece of equipment?

3b.

HospitalSkilled Nursing FacilityPhysician's OfficeDental OfficeFree-StandingUnknownOther (please specify)Other (please specify)Other (please specify)Other (please specify)

3c.

4. Is the device/drug/equipment category:if other, please specify:

5.

Not ApplicableSpecial Funds from User Fees + % of total 0.0%Special Funds (Other) + % of total 0.0%General Fund + % of total 0.0%Federal Funds/Grants + % of total 0.0%Other (Specify Below) 0.0%

Devices & Equipment (Complete this Section for each category of device that you regulate)

Section G. Characteristics of Regulated Entities (Devices & Equipment)

Program Funding

Please list the program funding sources to support the regulatory oversight functions for this category of device or equipment under state authority. (Please make sure percentages total 100%)

What Department, Program, Division, Branch, Board and/or Bureau do you represent?

What are the locations for which this device/equipment is approved, if different than indicated in 3a?

What is the total number of licenses, certifications, registration or other designation issued for this category?0

Select all that Apply

Select all that Apply and Enter Percentage

6.

Not ApplicableSpecial Funds from User Fees + % of total 0.0%Special Funds (Other) + % of total 0.0%General Fund + % of total 0.0%Federal Funds/Grants + % of total 0.0%Other (Specify Below) 0.0%

7. Please specify the timeframe for the data provided, by selecting:

if other, please specify:

8. Can the applicant obtain the necessary forms online to apply for initial licensure, certification, or registration?

9. Can the applicant obtain the necessary forms online to apply for renewal licensure, certification, or registration?

10. Can the applicant submit the initial application to the state department online?

11. Can the applicant submit the renewal application to the state department online?

12. Can the applicant pay initial fees online?

13. Can the applicant pay renewal fees online?

14. What is the general process for obtaining initial licensure, certification or registration:

ApplicationFeeDesk ReviewOnsite Review/InspectionDocumentation from other Agency (specify)Other (specify)

15.

if contracted out or delegated, please specify:

16. Are the fees associated with initial approval based on:if other, please specify:

17. Please provide the initial fee amount: $0.00

18.

19. What is the renewal cycle?if other, please specify:

20. Are there fees for renewals?If different than initial fee, please specify: $0.00

Is the initial licensing process contracted out or delegated to another entity (partially or wholly), or is this performed by state staff?

Initials and Renewals

Please list the program funding sources to support the regulatory oversight functions for this category of device or equipment under federal authority. (Please make sure percentages total 100%)

Is the license, certification or registration required to be periodically renewed as a condition of continued operation of the device or equipment?

Select all that Apply and Enter Percentage

Select all that Apply

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38California HealthCare Foundation

6.

Not ApplicableSpecial Funds from User Fees + % of total 0.0%Special Funds (Other) + % of total 0.0%General Fund + % of total 0.0%Federal Funds/Grants + % of total 0.0%Other (Specify Below) 0.0%

7. Please specify the timeframe for the data provided, by selecting:

if other, please specify:

8. Can the applicant obtain the necessary forms online to apply for initial licensure, certification, or registration?

9. Can the applicant obtain the necessary forms online to apply for renewal licensure, certification, or registration?

10. Can the applicant submit the initial application to the state department online?

11. Can the applicant submit the renewal application to the state department online?

12. Can the applicant pay initial fees online?

13. Can the applicant pay renewal fees online?

14. What is the general process for obtaining initial licensure, certification or registration:

ApplicationFeeDesk ReviewOnsite Review/InspectionDocumentation from other Agency (specify)Other (specify)

15.

if contracted out or delegated, please specify:

16. Are the fees associated with initial approval based on:if other, please specify:

17. Please provide the initial fee amount: $0.00

18.

19. What is the renewal cycle?if other, please specify:

20. Are there fees for renewals?If different than initial fee, please specify: $0.00

Is the initial licensing process contracted out or delegated to another entity (partially or wholly), or is this performed by state staff?

Initials and Renewals

Please list the program funding sources to support the regulatory oversight functions for this category of device or equipment under federal authority. (Please make sure percentages total 100%)

Is the license, certification or registration required to be periodically renewed as a condition of continued operation of the device or equipment?

Select all that Apply and Enter Percentage

Select all that Apply

21. What is the process for changing the fees?

AdministrativeLegislativeRegulatoryOther (specify)

22. How often are fees changed?if varies, please specify:

23.

24. Is documentation required for renewals (besides payment of fees)?if yes, please specify:

25. Is other routine, periodic oversight conducted?

26. If yes, is this periodic oversight:if other, please specify:

27. If yes, what is the required periodic oversight cycle:if other, please specify:

28. What is the process for updating or clarifying requirements?

StatutoryRegulationsAdministrative Bulletins or LettersLegal OpinionsOther (Specify)

29.

if other, please specify:

30. Are the regulatory requirements for this category current?if other, please specify:

31. Is there the authority to investigate complaints for this category?

32. What is the annual number of complaints?

Is this category of device or equipment required to meet standards in addition to state standards, in order to be licensed, certified or registered?

Complaints and Enforcement

Periodic Oversight and Requirements

When was the most recent change in fees? (Specify month/year or year)

Select all that Apply

Select all that Apply

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39Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

21. What is the process for changing the fees?

AdministrativeLegislativeRegulatoryOther (specify)

22. How often are fees changed?if varies, please specify:

23.

24. Is documentation required for renewals (besides payment of fees)?if yes, please specify:

25. Is other routine, periodic oversight conducted?

26. If yes, is this periodic oversight:if other, please specify:

27. If yes, what is the required periodic oversight cycle:if other, please specify:

28. What is the process for updating or clarifying requirements?

StatutoryRegulationsAdministrative Bulletins or LettersLegal OpinionsOther (Specify)

29.

if other, please specify:

30. Are the regulatory requirements for this category current?if other, please specify:

31. Is there the authority to investigate complaints for this category?

32. What is the annual number of complaints?

Is this category of device or equipment required to meet standards in addition to state standards, in order to be licensed, certified or registered?

Complaints and Enforcement

Periodic Oversight and Requirements

When was the most recent change in fees? (Specify month/year or year)

Select all that Apply

Select all that Apply

33. What are the consequences or enforcement remedies available for noncompliance with standards?

Findings of Deficiencies with Plan of CorrectionFines/Monetary PenaltiesMore frequent oversightTermination/RevocationOther (Specify)

34. What types of data or information is available to the public through your website for this category of equipment?Please provide a link to your website:

Name, addresses of currently-licensed (certified or registered) entities. Survey/investigation findings Number/types of complaints Final Compliance/Enforcement Information Officers or Executives Basic demographics about authorized beds/services Expiration date of license Penalties and fines Ownership Other (Specify) Other (Specify) Other (Specify)

35. What types of data or information is available to the public through other means?

Name, addresses of currently-licensed (certified or registered) entities. Survey/investigation findings Number/types of complaints Final Compliance/Enforcement Information Officers or Executives Basic demographics about authorized beds/services Expiration date of license Penalties and fines Ownership Other (Specify) Other (Specify) Other (Specify)

36. How is the information made available to the public?

Public Records Act requestOnline informationWalk-in requests to view filesOther (please specify)Other (please specify)Other (please specify)

Public Avaliability of Data

Select all that Apply

Select all that Apply

Select all that Apply

Select all that Apply

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40California HealthCare Foundation

33. What are the consequences or enforcement remedies available for noncompliance with standards?

Findings of Deficiencies with Plan of CorrectionFines/Monetary PenaltiesMore frequent oversightTermination/RevocationOther (Specify)

34. What types of data or information is available to the public through your website for this category of equipment?Please provide a link to your website:

Name, addresses of currently-licensed (certified or registered) entities. Survey/investigation findings Number/types of complaints Final Compliance/Enforcement Information Officers or Executives Basic demographics about authorized beds/services Expiration date of license Penalties and fines Ownership Other (Specify) Other (Specify) Other (Specify)

35. What types of data or information is available to the public through other means?

Name, addresses of currently-licensed (certified or registered) entities. Survey/investigation findings Number/types of complaints Final Compliance/Enforcement Information Officers or Executives Basic demographics about authorized beds/services Expiration date of license Penalties and fines Ownership Other (Specify) Other (Specify) Other (Specify)

36. How is the information made available to the public?

Public Records Act requestOnline informationWalk-in requests to view filesOther (please specify)Other (please specify)Other (please specify)

Public Avaliability of Data

Select all that Apply

Select all that Apply

Select all that Apply

Select all that Apply

37. Is data/information about the regulated entity routinely provided to:

Other state agencies State Legislature Local Government Federal Government Other (Specify) Other (Specify) Other (Specify)

38. How is the information made available to these other entities?

Reports/information required by statute or budget control languageReports/information required by federal grants/contractsData exchanges/transmission/accessUpon requestOther (please specify)Other (please specify)Other (please specify)

39.

40.

41.

Please provide the general state statutory cites authorizing oversight of this category.

Authorities

Please provide the general regulatory citations authorizing oversight of this category. If there are no state regulatory citations, enter "none".

Please provide the general federal regulatory citations authorizing oversight of this category, if applicable.

Select all that Apply

Select all that Apply

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41Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

1.Agency

DepartmentDivision/Board/Bureau

Branch/Committee/Section

2. Please provide your contact information.Name and Title

Telephone NumberE-mail Address

3a. What is the name of the license, certificate, registration, or other similar designation that you issue?

3b.

HospitalSkilled Nursing FacilityPhysician's OfficeDental OfficeFree-StandingOther (please specify)Other (please specify)Other (please specify)Other (please specify)

3c.

4. Is the facility/agency category:if other, please specify:

Please specify the numbers of this category of facility/agency/clinic/hospice:Licensed Only 0Certified Only 0

Licensed and Certified 0Licensed and Certified as a different category 0

Registered 0Other 0

Total number issued 0

5. If specified on the license, certificate or registration, please specify the number of:Beds 0

Participants 0

What Department, Program, Division, Branch, Board and/or Bureau do you represent?

Please list the types of facilities or places that can receive this category of license, certificate, registration or designation, if different than specified in 3a.

Please provide the total number of current licenses, certificates, or registrations issued for this category.0

Program Funding

Facilities, Places, Agencies, & Hospice(Compete this Section for each category that you regulate)

Section E. Characteristics of Regulated Entities (Facilities, Places, Agencies, & Hospice)

Select all that Apply

6.

Not ApplicableSpecial Funds from User Fees + % of total 0.0%Special Funds (Other) + % of total 0.0%General Fund + % of total 0.0%Federal Funds/Grants + % of total 0.0%Other (Specify Below) 0.0%

7.

Not ApplicableSpecial Funds from User Fees + % of total 0.0%Special Funds (Other) + % of total 0.0%General Fund + % of total 0.0%Federal Funds/Grants + % of total 0.0%Other (Specify Below) 0.0%

8. Please specify the timeframe for the data provided, by selecting:

if other, please specify:

9. Can the applicant obtain the necessary forms online to apply for initial licensure, certification, or registration?

10. Can the applicant obtain the necessary forms online to apply for renewal licensure, certification, or registration?

11. Can the applicant submit the initial application to the state department online?

12. Can the applicant submit the renewal application to the state department online?

13. Can the applicant pay initial fees online?

14. Can the applicant pay renewal fees online?

15. What are the requirements and general processes for obtaining initial licensure, certification or registration?

ApplicationFeeDesk ReviewOnsite Review/InspectionDocumentation from other AgencyCriminal Background CheckPrior Compliance HistoryOther (specify)

16. Are the fees associated with initial approval based on:if other, please specify:

17. Please provide the initial fee amount: $0.00

18.

19. What is the renewal cycle?if other, please specify:

20. Are there fees for renewals?

Please list the program funding sources to support the regulatory oversight functions for this category of facility, place, agency, or hospice under state authority. (Please make sure percentages total 100%)

Please list the program funding sources to support the regulatory oversight functions for this category of facility, place, agency, or hospice under federal authority. (Please make sure percentages total 100%)

Initials and Renewals

Is the license, certification or registration required to be periodically renewed to continue to provide services?

Select all that Apply

Select all that Apply and Enter Percentage

Select all that Apply and Enter Percentage

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42California HealthCare Foundation

6.

Not ApplicableSpecial Funds from User Fees + % of total 0.0%Special Funds (Other) + % of total 0.0%General Fund + % of total 0.0%Federal Funds/Grants + % of total 0.0%Other (Specify Below) 0.0%

7.

Not ApplicableSpecial Funds from User Fees + % of total 0.0%Special Funds (Other) + % of total 0.0%General Fund + % of total 0.0%Federal Funds/Grants + % of total 0.0%Other (Specify Below) 0.0%

8. Please specify the timeframe for the data provided, by selecting:

if other, please specify:

9. Can the applicant obtain the necessary forms online to apply for initial licensure, certification, or registration?

10. Can the applicant obtain the necessary forms online to apply for renewal licensure, certification, or registration?

11. Can the applicant submit the initial application to the state department online?

12. Can the applicant submit the renewal application to the state department online?

13. Can the applicant pay initial fees online?

14. Can the applicant pay renewal fees online?

15. What are the requirements and general processes for obtaining initial licensure, certification or registration?

ApplicationFeeDesk ReviewOnsite Review/InspectionDocumentation from other AgencyCriminal Background CheckPrior Compliance HistoryOther (specify)

16. Are the fees associated with initial approval based on:if other, please specify:

17. Please provide the initial fee amount: $0.00

18.

19. What is the renewal cycle?if other, please specify:

20. Are there fees for renewals?

Please list the program funding sources to support the regulatory oversight functions for this category of facility, place, agency, or hospice under state authority. (Please make sure percentages total 100%)

Please list the program funding sources to support the regulatory oversight functions for this category of facility, place, agency, or hospice under federal authority. (Please make sure percentages total 100%)

Initials and Renewals

Is the license, certification or registration required to be periodically renewed to continue to provide services?

Select all that Apply

Select all that Apply and Enter Percentage

Select all that Apply and Enter Percentage

If different than initial fee, please specify: $0.00

21. Is documentation required for renewals (besides payment of fees)?if yes, please specify:

22. What is the process for changing the fees?

AdministrativeLegislativeRegulatoryOther (specify)

23. How often are fees changed?if varies, please specify:

24. When was the most recent change in fees? (Specify month/year or year)

25. Is other routine, periodic oversight conducted?

26. If yes, is this periodic oversight:if other, please specify:

27a. If yes, what is the required periodic oversight cycle that is under state authority:if other, please specify:

27b. If yes, what is the required periodic oversight cycle that is under federal authority:if other, please specify:

28. Is any part of the oversight of the category contracted (wholly or partially) out or delegated to other entities? if yes, please specify:

29. What is the process for updating or clarifying requirements?

StatutoryRegulationsAdministrative Bulletins or LettersLegal OpinionsOther (Specify)

Periodic Oversight and Requirements

Select all that Apply

Select all that Apply

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43Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

If different than initial fee, please specify: $0.00

21. Is documentation required for renewals (besides payment of fees)?if yes, please specify:

22. What is the process for changing the fees?

AdministrativeLegislativeRegulatoryOther (specify)

23. How often are fees changed?if varies, please specify:

24. When was the most recent change in fees? (Specify month/year or year)

25. Is other routine, periodic oversight conducted?

26. If yes, is this periodic oversight:if other, please specify:

27a. If yes, what is the required periodic oversight cycle that is under state authority:if other, please specify:

27b. If yes, what is the required periodic oversight cycle that is under federal authority:if other, please specify:

28. Is any part of the oversight of the category contracted (wholly or partially) out or delegated to other entities? if yes, please specify:

29. What is the process for updating or clarifying requirements?

StatutoryRegulationsAdministrative Bulletins or LettersLegal OpinionsOther (Specify)

Periodic Oversight and Requirements

Select all that Apply

Select all that Apply

30a. What general compliance domains are included in oversight under state licensing authority?

Medical Services Admission, Transfer, DischargeNursing Services AdministrativePharmaceutical Services Policies and ProceduresDietary Services Assessments/Plan of Care/TreatmentsSurgery Services Medical RecordsLaboratory Services Infection ControlRadiologic Services Disaster Preparedness/Emergency ResponseAnesthesia Services Building Renovation/New ConstructionDietary Services Operational Use of SpaceOptional Services Laundry/HousekeepingStaffing levels/requirements/competencies Equipment and SuppliesGovernance Waste DisposalQuality Assurance Fire/Life Safety Patient/Resident/Client rights Utilities, Related Mechanical Systems, & Building MaintenanceOther (specify)Other (specify)Other (specify)

30b. What general compliance domains are included in oversight under federal authority?

Medical Services Admission, Transfer, DischargeNursing Services AdministrativePharmaceutical Services Policies and ProceduresDietary Services Assessments/Plan of Care/TreatmentsSurgery Services Medical RecordsLaboratory Services Infection ControlRadiologic Services Disaster Preparedness/Emergency ResponseAnesthesia Services Building Renovation/New ConstructionDietary Services Operational Use of SpaceOptional Services Laundry/HousekeepingStaffing levels/requirements/competencies Equipment and SuppliesGovernance Waste DisposalQuality Assurance Fire/Life Safety Patient/Resident/Client rights Utilities, Related Mechanical Systems, & Building MaintenanceOther (specify)Other (specify)Other (specify)

31.

if yes, please specify:

32. Are the regulatory requirements for this category current?if other, please specify:

33. Is there the authority to investigate complaints for this category?

34. What is the annual number of complaints?

Complaints and Enforcement

Is this category of facility required to meet standards in addition to state standards, in order to be licensed, certified or registered?

Select all that Apply

Select all that Apply

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44California HealthCare Foundation

30a. What general compliance domains are included in oversight under state licensing authority?

Medical Services Admission, Transfer, DischargeNursing Services AdministrativePharmaceutical Services Policies and ProceduresDietary Services Assessments/Plan of Care/TreatmentsSurgery Services Medical RecordsLaboratory Services Infection ControlRadiologic Services Disaster Preparedness/Emergency ResponseAnesthesia Services Building Renovation/New ConstructionDietary Services Operational Use of SpaceOptional Services Laundry/HousekeepingStaffing levels/requirements/competencies Equipment and SuppliesGovernance Waste DisposalQuality Assurance Fire/Life Safety Patient/Resident/Client rights Utilities, Related Mechanical Systems, & Building MaintenanceOther (specify)Other (specify)Other (specify)

30b. What general compliance domains are included in oversight under federal authority?

Medical Services Admission, Transfer, DischargeNursing Services AdministrativePharmaceutical Services Policies and ProceduresDietary Services Assessments/Plan of Care/TreatmentsSurgery Services Medical RecordsLaboratory Services Infection ControlRadiologic Services Disaster Preparedness/Emergency ResponseAnesthesia Services Building Renovation/New ConstructionDietary Services Operational Use of SpaceOptional Services Laundry/HousekeepingStaffing levels/requirements/competencies Equipment and SuppliesGovernance Waste DisposalQuality Assurance Fire/Life Safety Patient/Resident/Client rights Utilities, Related Mechanical Systems, & Building MaintenanceOther (specify)Other (specify)Other (specify)

31.

if yes, please specify:

32. Are the regulatory requirements for this category current?if other, please specify:

33. Is there the authority to investigate complaints for this category?

34. What is the annual number of complaints?

Complaints and Enforcement

Is this category of facility required to meet standards in addition to state standards, in order to be licensed, certified or registered?

Select all that Apply

Select all that Apply

35a. What are the consequences or enforcement remedies available for noncompliance with standards, under state authority?

Findings of Deficiencies with Plan of CorrectionFines/Monetary PenaltiesMore frequent oversightProbationTermination/RevocationTemporary Suspension OrderBan on AdmissionsBan on Payment for New AdmissionsReceivership/Temporary ManagerOther (Specify)

35b. What are the consequences or enforcement remedies available for noncompliance with standards, under federal authority?

Findings of Deficiencies with Plan of CorrectionFines/Monetary PenaltiesMore frequent oversightProbationTermination/RevocationTemporary Suspension OrderBan on AdmissionsBan on Payment for New AdmissionsReceivership/Temporary ManagerOther (Specify)

36. What types of data or information is available to the public through your website for this category?Please provide a link to your website:

Not Applicable Name, addresses of currently-licensed (certified or registered) entities. Survey/investigation findings Number/types of complaints Final Compliance/Enforcement Information Officers or Executives Basic demographics about authorized beds/services Expiration date of license Penalties and fines Ownership Other (Specify) Other (Specify) Other (Specify)

Public Availability of Information

Select all that Apply

Select all that Apply

Select all that Apply

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45Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

35a. What are the consequences or enforcement remedies available for noncompliance with standards, under state authority?

Findings of Deficiencies with Plan of CorrectionFines/Monetary PenaltiesMore frequent oversightProbationTermination/RevocationTemporary Suspension OrderBan on AdmissionsBan on Payment for New AdmissionsReceivership/Temporary ManagerOther (Specify)

35b. What are the consequences or enforcement remedies available for noncompliance with standards, under federal authority?

Findings of Deficiencies with Plan of CorrectionFines/Monetary PenaltiesMore frequent oversightProbationTermination/RevocationTemporary Suspension OrderBan on AdmissionsBan on Payment for New AdmissionsReceivership/Temporary ManagerOther (Specify)

36. What types of data or information is available to the public through your website for this category?Please provide a link to your website:

Not Applicable Name, addresses of currently-licensed (certified or registered) entities. Survey/investigation findings Number/types of complaints Final Compliance/Enforcement Information Officers or Executives Basic demographics about authorized beds/services Expiration date of license Penalties and fines Ownership Other (Specify) Other (Specify) Other (Specify)

Public Availability of Information

Select all that Apply

Select all that Apply

Select all that Apply

37. What types of data or information is available to the public through other means?

Name, addresses of currently-licensed (certified or registered) entities. Survey/investigation findings Number/types of complaints Final Compliance/Enforcement Information Officers or Executives Basic demographics about authorized beds/services Expiration date of license Penalties and fines Ownership Other (Specify) Other (Specify) Other (Specify)

38. How is the information made available to the public?

Public Records Act requestWalk-in requests to view filesOther (please specify)Other (please specify)Other (please specify)

39. Is data/information about the regulated entity routinely provided to:

Other state agencies State Legislature Local Government Federal Government Other (Specify) Other (Specify) Other (Specify)

40. How is the information made available to these other entities?

Reports/information required by statute or budget control languageReports/information required by federal grants/contractsData exchanges/transmission/accessUpon requestOther (please specify)Other (please specify)Other (please specify)

41.

42.

43. Please provide the general federal regulatory citations authorizing oversight of this category, if applicable.

Please provide the general regulatory citations authorizing oversight of this category. If there are no state regulatory citations, enter "none".

AuthoritiesPlease provide the general state statutory cites authorizing oversight of this category.

Select all that Apply

Select all that Apply

Select all that Apply

Select all that Apply

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46California HealthCare Foundation

1.Agency

DepartmentDivision/Board/Bureau

Branch/Committee/Section

2. Please provide your contact information.Name and Title

Telephone NumberE-mail Address

3. What is the name of the regulated category of professionals?

4. Is the professional Category:if other, please specify:

Please specify the numbers of this category of professionals:

5. Are there restrictions to the locations in which this category of professional can practice?

if yes, please specify:

6.

Not ApplicableSpecial Funds from User Fees + % of total 0.0%Special Funds (Other) + % of total 0.0%General Fund + % of total 0.0%Federal Funds/Grants + % of total 0.0%Other (Specify Below) 0.0%

7.

Not ApplicableSpecial Funds from User Fees + % of total 0.0%Special Funds (Other) + % of total 0.0%General Fund + % of total 0.0%Federal Funds/Grants + % of total 0.0%Other (Specify Below) 0.0%

8. Please specify the timeframe for the data provided, by selecting:if other, please specify:

Program Funding

Please list the program funding sources to support the regulatory oversight functions for this category of professionals under federal authority. (Please make sure percentages total 100%)

What Department, Program, Division, Branch, Board and/or Bureau do you represent?

Please list the program funding sources to support the regulatory oversight functions for this category of professionals under state authority. (Please make sure percentages total 100%)

Professionals(Complete this Section for each category of professional that you regulate)

Section F. Characteristics of Regulated Entities (Professionals)

Select all that Apply and Enter Percentage

Select all that Apply and Enter Percentage

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47Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

9. Can the applicant obtain the necessary forms online to apply for initial licensure, certification, or registration?

10. Can the applicant obtain the necessary forms online to apply for renewal licensure, certification, or registration?.11. Can the applicant submit the initial application to the state department online?

12. Please provide the initial fee amount: $0.00

13. Can the applicant submit the renewal application to the state department online?

14. Can the applicant pay initial fees online?

15. Can the applicant pay renewal fees online?

16. What are the general requirements for obtaining initial licensure, certification or registration:

ApplicationFeeDesk ReviewProof of Education/TrainingTestingOnsite Review/InspectionDocumentation from other AgencyAgeReciprocityCriminal Background Check

Minimum Number of education/training Hours (Specify)Other (specify)

17. Are the fees associated with initial approval based on:if other, please specify:

18.

19. What are the general requirements to renew the license, certificate or registration?

FeesEvidence of Continuing Education

Minimum Number of Continuing Education Hours (Specify)Other (Specify)Other (Specify)Other (Specify)

20a. What is the renewal cycle that is under state authority?if other, please specify:

20b. What is the renewal cycle that is under federal authority?if other, please specify:

21. Are there fees for renewals?If different than initial fee, please specify: $0.00

Initials and Renewals

Is the license, certification or registration required to be periodically renewed to continue to provide services as this category of professional?

Select all that Apply

Select all that Apply

22. What is the process for changing the fees?

AdministrativeLegislativeRegulatoryOther (specify)

23. How often are fees changed?if varies, please specify:

24.

25. Is documentation required for renewals (besides payment of fees)?if yes, please specify:

26a. Is other routine, periodic oversight conducted?

26b. If yes, is this periodic oversight:if other, please specify:

26c. If yes, what is the required periodic oversight cycle:if other, please specify:

27. Is any part of the oversight of this professional category contracted (wholly or partially) or delegated to other entities?if yes, please specify:

28. What is the process for updating or clarifying requirements?

StatutoryRegulationsAdministrative Bulletins or LettersLegal OpinionsOther (Specify)

29.

if other, please specify:

30. Are the regulatory requirements for this category current?if other, please specify:

31. Is there the authority to investigate complaints for this category?

32. What is the annual number of complaints?

When was the most recent change in fees? (Specify month/year or year)

Periodic Oversight and Requirements

Complaints and Enforcement Authority

Is this category of professionals required to meet standards in addition to state standards, in order to be licensed, certified or registered?

Select all that Apply

Select all that Apply

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48California HealthCare Foundation

22. What is the process for changing the fees?

AdministrativeLegislativeRegulatoryOther (specify)

23. How often are fees changed?if varies, please specify:

24.

25. Is documentation required for renewals (besides payment of fees)?if yes, please specify:

26a. Is other routine, periodic oversight conducted?

26b. If yes, is this periodic oversight:if other, please specify:

26c. If yes, what is the required periodic oversight cycle:if other, please specify:

27. Is any part of the oversight of this professional category contracted (wholly or partially) or delegated to other entities?if yes, please specify:

28. What is the process for updating or clarifying requirements?

StatutoryRegulationsAdministrative Bulletins or LettersLegal OpinionsOther (Specify)

29.

if other, please specify:

30. Are the regulatory requirements for this category current?if other, please specify:

31. Is there the authority to investigate complaints for this category?

32. What is the annual number of complaints?

When was the most recent change in fees? (Specify month/year or year)

Periodic Oversight and Requirements

Complaints and Enforcement Authority

Is this category of professionals required to meet standards in addition to state standards, in order to be licensed, certified or registered?

Select all that Apply

Select all that Apply

33a. What are the consequences or enforcement remedies available for noncompliance with standards, under state authority?

Findings of Deficiencies with Plan of CorrectionFines/Monetary PenaltiesMore frequent oversightProbation, Proctering, or PreceptorshipDrug Diversion ProgramTermination/RevocationOther (Specify)

33b. What are the consequences or enforcement remedies available for noncompliance with standards, under federal authority?

Findings of Deficiencies with Plan of CorrectionFines/Monetary PenaltiesMore frequent oversightProbation, Proctering, or PreceptorshipTermination/RevocationOther (Specify)

34. What types of data or information is available to the public through your website for this category of professional?Please provide a link to your website:

Not Applicable Name, addresses of currently-licensed (certified or registered) entities. Survey/investigation findings Number/types of complaints Final Compliance/Enforcement Information Expiration date of license Penalties and fines Ownership Other (Specify) Other (Specify) Other (Specify)

35. What types of data or information is available to the public through other means?

Name, addresses of currently-licensed (certified or registered) entities. Survey/investigation findings Number/types of complaints Final Compliance/Enforcement Information Expiration date of license Penalties and fines Ownership Other (Specify) Other (Specify) Other (Specify)

Public Availability of Data

Select all that Apply

Select all that Apply

Select all that Apply

Select all that Apply

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49Taking Inventory: A Framework for Understanding Health Care Regulation and Oversight in CA

33a. What are the consequences or enforcement remedies available for noncompliance with standards, under state authority?

Findings of Deficiencies with Plan of CorrectionFines/Monetary PenaltiesMore frequent oversightProbation, Proctering, or PreceptorshipDrug Diversion ProgramTermination/RevocationOther (Specify)

33b. What are the consequences or enforcement remedies available for noncompliance with standards, under federal authority?

Findings of Deficiencies with Plan of CorrectionFines/Monetary PenaltiesMore frequent oversightProbation, Proctering, or PreceptorshipTermination/RevocationOther (Specify)

34. What types of data or information is available to the public through your website for this category of professional?Please provide a link to your website:

Not Applicable Name, addresses of currently-licensed (certified or registered) entities. Survey/investigation findings Number/types of complaints Final Compliance/Enforcement Information Expiration date of license Penalties and fines Ownership Other (Specify) Other (Specify) Other (Specify)

35. What types of data or information is available to the public through other means?

Name, addresses of currently-licensed (certified or registered) entities. Survey/investigation findings Number/types of complaints Final Compliance/Enforcement Information Expiration date of license Penalties and fines Ownership Other (Specify) Other (Specify) Other (Specify)

Public Availability of Data

Select all that Apply

Select all that Apply

Select all that Apply

Select all that Apply

36. How is the information made available to the public?

Public Records Act requestOnline informationWalk-in requests to view filesOther (please specify)Other (please specify)Other (please specify)

37. Is data/information about the regulated entity routinely provided to:

Other state agencies State Legislature Local Government Federal Government Other (Specify) Other (Specify) Other (Specify)

38. How is the information made available to these other entities?

Reports/information required by statute or budget control languageReports/information required by federal grants/contractsData exchanges/transmission/accessUpon requestOther (please specify)Other (please specify)Other (please specify)

39.

40.

41.

Please provide the general state statutory citations authorizing oversight of this category.

Authorities

Please provide the general regulatory citations authorizing oversight of this category. If there are no state regulatory citations, enter "none".

Please provide the general federal regulatory citations authorizing oversight of this category, if applicable.

Select all that Apply

Select all that Apply

Select all that Apply